HK1082173B - Generalized metronome for modification of biorhythmic activity - Google Patents

Description

Universal metronome for regulating biorhythmic activity

Cross Reference to Related Applications

This patent application claims priority from us provisional patent application 60402378 entitled "Generalized meters for modification of biorhythmic activity" filed on 9/8/2002 by Gavish, assigned to the assignee of the present patent application, the disclosure of which is hereby incorporated by reference.

Technical Field

The present invention relates to medical devices, and more particularly to training devices for regulating biorhythmic activity of a user.

Background

Physical exercise often involves the modulation of multi-phase biorhythmic activity such as respiration. In a variety of cardiovascular diseases including Congestive Heart Failure (CHF) and pulmonary diseases including Chronic Obstructive Pulmonary Disease (COPD), the breathing pattern exhibits irregularities. These irregularities are known markers of death and morbidity of the associated disease. Typical irregularities include: tidal (Cheyne-Stokes) breathing (the case of recurrent central apneas alternating with hyperpnoea), amplitude-modulated (periodic) breathing with adjustments made approximately once per minute, repetitive sighs, amplitudes and periods appearing as random breaths. A reduction in breathing pattern irregularities means an improvement in health. Cardiovascular reflexes control blood pressure and blood volume, minimizing fluctuations in blood supply to tissues (homeostasis), and impairment of cardiovascular reflexes is of great clinical significance in cardiovascular and psychosomatic diseases.

Us patents 5076281, 5800337, and 6090037 to Gavish, the disclosures of which are incorporated herein by reference, describe methods and apparatus for modulating biorhythmic activity by measuring one or more variables of a user. These patents describe the generation of stimuli that are provided to a user to alter the user's biorhythmic activity in a predetermined manner relative to the monitored biorhythmic activity.

Us patent 5423328 filed by Gavish, the disclosure of which is incorporated herein by reference, describes a pressure sensing device for monitoring respiration and, in particular, a method for detecting and monitoring changes in circumference of the chest and abdomen of a user due to respiration. Us patent 4580574 filed by Gavish, the disclosure of which is incorporated herein by reference, describes a method of monitoring attributes of living tissue in a non-invasive manner.

Us patent 6090037 filed by Gavish and incorporated herein by reference describes a method of regulating rhythmic physical activity of a user by monitoring the biorhythmic activity of the user and providing the user with a pattern of stimulation similar to, but different from, the biorhythmic activity being monitored in such a way as to drive changes in the biorhythmic activity as the user automatically follows.

PCT published application WO0102049 filed by Gavish et al, and incorporated herein by reference, describes techniques for improving the health of a user, including: a first sensor for measuring a first physiological variable representing voluntary action of a user; a second sensor for measuring a second physiological variable, the second physiological variable not being completely under direct active control of the user; circuitry for receiving the first and second sensor signals from the first and second sensors, respectively, and generating an output signal in response thereto that directs a user to modify a parameter of the voluntary action. The' 049 publication also describes an interventional diagnostic system that includes a locally located local computing device that applies an intervention to a user in the field and receives one or more input signals from one or more sensors coupled to the user that are indicative of a physiological condition of the user. One embodiment described therein comprises: monitoring respiratory motion using a sensor; the user is instructed to adjust the breathing pattern in an attempt to optimize the blood oxygenation measured by the second sensor.

Us patent 4195626, filed by Schweizer and incorporated herein by reference, describes a biofeedback chamber for applying auditory, visual or tactile stimuli to a subject according to a rhythmic pattern. The subject's response is measured, analyzed and used to control the stimulus.

U.S. patent 5678571, filed by Brown, and incorporated herein by reference, describes a method of treating a medical condition in a patient comprising: selecting a psychological strategy for treating a medical condition; the electronic instructions of the interactive video game are then encoded. The game implements the mental strategy, loading electronic instructions into a microprocessor-based unit equipped with a display for displaying the video game. The game includes scoring instructions to perform a quantitative analysis of the medical condition of the patient; a consultation instruction; and self-care (self-care) instructions. The video game may be used with a physiological variable measuring device connected to the microprocessor-based unit.

U.S. patent 5596994, filed by Bro and incorporated herein by reference, describes an automated, interactive positive motivation system that enables doctors, consultants and trainers to generate and send a series of motivational messages and/or questions to a client to alter or reinforce specific behavioral problems.

Us patent 5590282 to Clynes and us patent 4526078 to Chadabe, which describe methods of enabling computers to compose music, the disclosures of which are incorporated herein by reference.

Us patent 5596994 filed by Knispel, incorporated herein by reference, describes a method of converting a subject's electroencephalogram into music, thereby sensing and controlling various psychological and physiological states of the subject.

U.S. patent 5596994, filed by Yagi and incorporated herein by reference, describes an abdominal breathing training system. The abdominal region attached sensors measure the abdominal breathing state of the person and compare the detected breathing pattern with an ideal breathing pattern.

The incorporated by reference U.S. patent 5827179 to Lichter et al describes a real-time biometric data processing PC card for inputting and processing biometric data from one or more biometric data sensors and interacting with other real-time biometric data processing PC cards.

U.S. patent 6001065, filed by DeVito and incorporated herein by reference, describes a method of measuring bioelectric signals, such as electroencephalography and Electromyography (EMG) signals, of a control system and performing a Fast Fourier Transform (FFT) analysis. Passive and active interaction with various electronic media, such as video games, movies, music, virtual reality, and computer animation, is also described.

U.S. patent 6561908, filed by Hoke and incorporated herein by reference, describes a gaming device having a metronome system. The metronome system includes a CPU that reads game state data based on a check-back rate-determined signal (tick). The CPU causes the sound file to change whenever a signal is present, thereby coordinating the multiple sound recordings in a rhythm or other manner. The invention is described as providing a gaming device with enhanced sound and music capabilities, thereby increasing the enjoyment of the gaming device player.

U.S. patent 5850048 filed by Ruf and incorporated herein by reference, describes a metronome unit comprising: an electronic metronome and a keyboard associated with the input of a music signal including the number of beats per bar. The unit further comprises: timing means for generating an electronic version of the music signal; a memory for storing information related to the music signal; and an electronic controller. The controller stores information indicative of a music signal input through the keypad, converts the signal generated by the timing device into a visual representation of the music signal suitable for viewing on the display, and updates the display according to the tempo of each bar of the music signal, thereby making the user visually aware of the correct tempo of the bar. The keypad may also include a speed (tempo) key and a set of numeric keys to facilitate entry of a desired speed, as well as one or more speed preset keys.

U.S. patent 5751825, filed by Myers et al, and incorporated herein by reference, describes a device that includes a headset and an electronic metronome. The earphone includes: two ear cups (earups), a first set of transducers (transducers) in each ear cup for receiving and reproducing an electronic audio signal from an external source; an electrically driven metronome circuit for use as a speed device in the ear cup; a second set of transducers in each ear cup for producing audio signals from the metronome circuit; a speed control switch for increasing and decreasing the time beats from the metronome circuit.

Us patent 5515764 filed by Rosen, and incorporated herein by reference, describes an electronic metronome device for producing accurately timed and tuned rhythms and pitches (pitch), preprogrammed for specific scales (scales) or modes (modes), arpegps, chords, and exercise music. The combination of the microprocessor and user interface stores these musical exercises and retrieves them from electronic memory, inputs them to the signal processor, amplifies and modifies them, and then outputs them to a speaker, optical display or audio output.

Us patent 5447089 filed by marras and incorporated herein by reference, describes an electronic programmable metronome with foot switches that allows the user to adjust the tempo (tempo) over a continuous range without having to take his hands off the instrument or interrupt the game. The metronome unit includes a display for making menu selections, prompts and visual prompts for adjusting tempo and selecting the type of click in the beat pattern. The microcontroller of the metronome may be programmed with a combination of time signals, cadences or patterns and desired cues or accents.

U.S. patent 5402188, filed by Wayne and incorporated herein by reference, describes a speed regulating goggle that includes a speed regulating device that delivers rhythmic or periodic visual signals to the swimmer. The flashing signal provides a metronome-like reference for adjusting the stroke of the swimmer. The frequency of the flashing signal may be adjusted to correspond to the pace desired by the swimmer.

U.S. patent 6086379, filed by Pendergast et al, and incorporated herein by reference, describes a training system and method for improving the biomechanics, distance per stroke and aerobic metabolism of a swimmer. The system employs a computer interface that allows a coach or swimmer to input specific training strategies using a pace light and timing system, or using a training program built into the system. The system provides a generator to collect data from the swimmer. The system comprises: (a) the swimming goggles with the LEDs are communicated with the swimmers through flashing signals and the like to tell the swimmers which part of the swimming stroke the swimmers should be in, so that the swimmers are assisted to reach a specific stroke frequency; and (b) a plurality of computer controlled pace light bars to assist the swimmer in achieving a suitable swimming speed.

U.S. patent 5921890, filed by milty and incorporated herein by reference, describes a programmable pacing device for assisting a user in achieving a desired pace or speed. The device may generate a plurality of different audible signals, each signal transmitting selected pacing information to the user. Athletes may use the device to assist in training or racing, or in medical applications, for example as a walking pace device, to assist in active medical regimens (proactive medical regiments), for example in the treatment of parkinson's disease, or other physiological therapeutic activities.

U.S. patent 5027686, filed by Ishikawa, and incorporated herein by reference, describes an electronic metronome comprising: a circuit to set a desired speed; a circuit for generating a speed signal corresponding to a desired speed in time; a circuit to set a desired time period; for generating an end-of-time signal corresponding to the last moment of the expected time period in time. A sound generator receives the velocity signals and the end-of-time signals for generating velocity sounds for each of the velocity signals and end-of-time sounds for the end-of-time signals. After the time-ending sound is generated, the control circuit stops generating the speed sound.

Us patent 4733593 filed by Rothbart, incorporated herein by reference, describes a microprocessor controlled metronome in which: the type (strong or weak), pattern (order and number of strong and weak) and frequency of beats depends on the data stored in a memory, which may be manually programmed using a keyboard or the like, and which is capable of storing information to produce metronome beats of different types, patterns and relative frequencies combined in various orders to produce beat chapters comprising one or more of these orders, and the memory may store a plurality of such chapters and produce corresponding beats on command.

U.S. patent 5592143, filed by Romney et al and incorporated herein by reference, describes a pulsed-tone timing method. At an initial pulse rate, a pulsed auditory guidance tone is initiated. Controlling the pulse rate so as to repeatedly: (i) increasing the pulse rate to an intermediate pulse rate over a period of time; and (b) abruptly decreasing the pulse rate to a decreased pulse rate intermediate the intermediate pulse rate and the previous pulse rate until a predetermined final pulse rate is reached. The pulse rate may be controlled such that subsequent intermediate pulse rates pulse at a faster rate than the previous intermediate pulse rate.

Us patent 6212135 filed by Schreiber and incorporated herein by reference describes a device for assisting an individual to participate in a targeted breathing session comprising at least one breathing cycle. The device generates a first sensory cue corresponding to an expiratory phase of the breathing cycle; and generating a second sensory cue that corresponds to an inspiratory phase of the respiratory cycle. The device repeatedly generates the first and second sensory cues at a particular rate, depending on a user selected or predetermined program, for the duration of the targeted breathing session. In one embodiment of the device, the light projecting sphere visually produces the sensory cue. In another embodiment, the sensory cue is auditory.

Us patent 4711585, filed by Fresquez et al, incorporated herein by reference, describes a device for providing a pregnant woman with a perceptible cue signal to synchronize her breathing with the cue signal to facilitate delivery. The device includes an oscillator with a selectable frequency and duty cycle that drives a physiologically-perceptible transducer.

United states patent 4583443, filed by senghas et al, and incorporated herein by reference, describes an electronic metronome for training students with music talents in various rhythmic patterns.

Us patent 4974483 filed by Luzzatto, incorporated herein by reference, describes a programmable electronic metronome capable of registering the rhythm (meter) and tempo characteristics of any musical piece, producing a very harsh, perceptible (e.g., acoustic) signal representing these characteristics in the proper sequence when the musical piece is played.

The following U.S. patents, which are hereby incorporated by reference, may be of reference:

D44923662017696179723D430810D4300456015948D389080D388340D3788995586088D368949D360144D3601435417137D351800D3431865214228D323469D319791

D31551849826424759253D2957284649794462933146128414602551446229744427524380185435441243331724237549421887442044004193257D253399D249936

4090355407094440181314014167401290139968333945292394240464073245959230545356751950614366741432185342130934173168416340940820293991648

the following articles, to which reference may be made, are hereby incorporated by reference:

cooke et al, "Controlled breakdown protocols protocol and Automiccardio pulmonary rhytems", American Journal of Physiology 274: H709-H718 (1998);

pitzalis et al, "Effect of respiratory rate on the correlation between the inter and the syllic blood pressure fluctuations: aftertaste-dependent phenomenon ", cardio regional Research 38: 332-339 (1998);

bernard et al, "Effect of cutting on oxygen analysis and design in chlorine health, The Lancet 351: 1308 charge 1311 (1998);

mortara et al, "Absolute awake respiratory images common in innovative heart failure and mass prediction evaluation of automatic tone by analysis of heart rate failure", Circulation 96: 246, 252 (1997);

la Rover et al, "Baroreflex sensitivity and heart-rate variability introduction of total heart rhythm after myocardial introduction", the Lancet 351: 478-484 (1998);

gimondo et al, "A new method for evaluating small interactive using duplex Doppler sound", AJR American Journal of Roentgenology 168 (1): 187-192(1997).

Disclosure of Invention

In some embodiments of the present invention, an apparatus for beneficially modifying biorhythmic activity of a user, comprises: a metronome for generating and dynamically modifying the multi-stage rhythmic output signal. Typically, the biorhythmic activity includes respiration, and the device configures the output signal to direct the user to modify one or more temporal parameters of the respiration. Typically, the device does not include any physiological sensors. Alternatively, the device does not include a physiological sensor (e.g., a respiration sensor), but the device receives data from the sensor prior to instructing the user to modify the time parameter, and not during generation and modification of the output signal.

Typically, the output signal includes an intelligible stimulus, such as a sound pattern and/or a dynamic graphical pattern. Typically, the stimulus is used to adjust the user's breathing by training the user to initiate a new breathing pattern. For example, the output signal may direct the user to change the timing of inspiration and expiration, thereby decreasing the inspiratory-expiratory ratio. For some interventions it is desirable to reduce this ratio, for example from a pre-intervention level of typically 1: 1 or 1: 2 to 1: 4. For some interventions, the new breathing pattern includes additional phases that are not typically included in the conventional, unguided breathing pattern. For example, conventional breathing typically includes two phases: inspiration and expiration. The device may be configured to output a signal to instruct the user to increase the breath hold and/or post-expiration pause phase.

During a typical use period, the user selects a stored training pattern and activates the device to generate an output signal in response to the pattern. Typically, the user uses the device for multiple periods of use that extend over a period of time, usually measured in days, months or years. Typically, each use period is about 10 to 20 minutes in length, and most typically about 15 minutes in length. Typically, the user configures the device to gradually adjust the training pattern over the period of time, which often helps the cardiovascular, pulmonary, and nervous systems adapt to dynamic changes developed by the training. Use of the device often results in a protocol schedule that is more consistent with the training behavior. Without this device, subjects requiring respiratory training often do not adequately adhere to the protocol schedule of training activities, e.g., due to boredom or lack of self-discipline.

Frequent use of the device may increase the degree of active control of the user over disease-related breathing irregularities, such as those described in the background of the invention. Such frequent use is beneficial in reducing mortality and morbidity associated with some medical conditions. For example, the use of the device is advantageous for the treatment of the following diseases:

● some cardiovascular diseases, including Congestive Heart Failure (CHF);

● some lung diseases, including Chronic Obstructive Pulmonary Disease (COPD);

● certain neurological disorders such as phobias (panic disorders);

● hypertension; and

● such as hypermobility in children.

The techniques described herein may be used in conjunction with the techniques described in (a) U.S. patent application 09611304 entitled "interventional-diagnostic device" filed on 7/6/2000, (b) PCT publication WO0102049 filed on Gavish et al, and/or (c) us patent application 10323596 filed on 12/13/2002 by Gavish, which are assigned to the assignee of the present patent application, the disclosures of which are incorporated herein by reference. Alternatively or additionally, the techniques described herein may be used in conjunction with techniques described in one or more of the references described in the background section of this patent application.

Although the user of the device, i.e., the person whose biorhythmic activity is modulated by the device, is sometimes described as programming and/or configuring the device, such programming and/or configuration may be performed by other than the user, such as by a health care worker or training instructor who configures and/or programs the device remotely, for example, through the user interface of the device or by telephone or through a network connection.

There is therefore provided, in accordance with an embodiment of the present invention, apparatus for an object, including:

a memory for storing a set of computer instructions,

wherein the memory has stored thereon an indication of an initial form of the multi-stage biorhythmic activity pattern and an expected form of the multi-stage biorhythmic activity pattern,

wherein the ratio of the durations of the two phases in the expected form is different from the ratio of the durations of the corresponding phases in the initial form, an

Wherein at least one phase of the multi-phase biorhythmic activity pattern corresponds to a respective phase of one multi-phase biorhythmic activity of the subject; and

a stimulation unit for executing the stored instructions and producing a time-varying stimulus in response to execution of the instructions, said time-varying stimulus: (a) substantially unresponsive to ongoing measurements of the multi-phase biorhythmic activity during generation of the time-varying stimulus; and (b) having a multi-phase pattern characterized by a series of transitional forms between said initial form and said desired form that direct said subject to modulate biorhythmic activity.

For some applications, the stimulation unit is for generating a time-varying stimulation having the multi-phase pattern, and the durations of the transitional forms in the series vary linearly in time. Alternatively, the stimulation unit is adapted to generate a time-varying stimulation having the multi-phase pattern, and the durations of the transitional forms in the series are geometrically varying in time.

In one embodiment, the initial form has a first number of phases and the expected form has a second number of phases, the first number not being equal to the second number, and the memory has stored thereon an indication of the initial form and the expected form having a different number of phases.

In one embodiment, the initial form has a greater number of phases than the expected form, and the memory indicates a phase that is present in the initial form but not in the expected form by setting a duration of the phase equal to 0 in the expected form. Alternatively, the expected form has a greater number of phases than the initial form, and the memory indicates a phase in the initial form that is present in the expected form but not in the initial form by setting a duration of the phase equal to 0. Still alternatively, the initial form and the expected form have the same number of phases, and the memory has stored thereon an indication of the initial form and the expected form having the same number of phases.

In one embodiment, the memory has stored thereon an indication of the initial form and the expected form prior to use of the apparatus by a subject.

In an embodiment, the time-varying stimulus comprises at least one stimulus selected from the list consisting of an image, an alpha-numeric text, a sound pattern, a dynamic image pattern and a visual cue, and the stimulus unit comprises a visual stimulator for generating the selected time-varying stimulus. In an embodiment, the time-varying stimulation comprises pressure, and the stimulation unit comprises a pressure applicator for applying the pressure to a body part of the subject. In an embodiment, the time-varying stimulation comprises massage, and the stimulation unit comprises a massage device for massaging a body part of the subject. In an embodiment, the time-varying stimulation comprises mechanical energy, and the stimulation unit comprises a mechanical stimulator for applying the mechanical energy to a body part of the subject. In one embodiment, the time-varying stimulation comprises an electrical current, and the stimulation unit comprises an electrical stimulator for applying the electrical current to a body part of the subject. In one embodiment, the time-varying stimulus is in the form of a game, and the stimulus unit comprises a game generator for altering parameters of the game to direct the subject to modulate the multi-phase biorhythmic activity.

For some applications, the stimulation unit is configured to send the time-varying stimulation to the subject over a telephone network. Alternatively, the stimulation unit is configured to send the time-varying stimulation to the subject over a wide area network.

In an embodiment, the apparatus comprises a muscle stimulator for working with said stimulation unit and applying an electrical current configured to stimulate a muscle of said subject to said muscle.

In an embodiment, the stimulation unit is for configuring the time-varying stimulation so as to increase tissue oxygenation of the subject, increase mechanical compliance (mechanical compliance) of blood vessels of the subject, decrease peripheral resistance (peripheral impedance) of small blood vessels of the subject, increase heart rate variability of the subject, and/or increase baroreflex (baroeflex) sensitivity of the subject.

In one embodiment, the device comprises a movement stimulator for working with said stimulation unit and generating a movement stimulus directing said subject to move said subject's body limb.

For some applications, the stimulation unit is to generate the time-varying stimulation while the subject is sleeping. For some applications, the stimulation unit is to generate the time-varying stimulation when the subject mechanically breathes.

In one embodiment, the time-varying stimulus comprises music. For some applications, the stimulation unit includes a music synthesizer for generating the music.

In an embodiment, the stimulation unit is adapted to generate a time-varying stimulus which is substantially not responsive to ongoing measurements of the physiological variable of the subject during generation of the time-varying stimulus. In an embodiment, the stimulation unit is adapted to generate a time-varying stimulus which is not responsive to a measurement of a physiological variable of the subject during use of the apparatus by the subject.

In one embodiment, the device comprises a sensor for detecting a physiological event and generating an event signal in response to the physiological event, the device being adapted to receive the event signal before said stimulation unit generates said time-varying stimulation, and the stimulation unit being adapted to start generating said time-varying stimulation in response to the event signal. For some applications, the apparatus is configured to configure the initial form at least partially in response to a parameter of the event signal. In one embodiment, the physiological event comprises a segment of sleep apnea and the sensor is configured to detect the segment of sleep apnea.

In one embodiment, the memory is for storing a plurality of training protocols having respective indications of respective initial and expected forms, the stimulation unit comprises a user interface for causing the subject to select one of the plurality of training protocols, and the stimulation unit is for generating the time-varying stimulation in response to the selection. For some applications, the user interface includes a telephone. Alternatively, the user interface comprises a user interface of an audio playback device. Still alternatively, the user interface comprises a user interface of a general purpose computer.

In an embodiment, the stimulation unit is adapted to generate the time-varying stimulation when the subject is unconscious. For some applications, the stimulation unit is for generating the time-varying stimulation when the subject is coma. For other applications, the stimulation unit is for generating the time-varying stimulation when the subject is anesthetized.

In one embodiment, the multi-phase biorhythmic activity includes respiration by the subject, and the stimulation unit is to configure the time-varying stimulation to direct the subject to adjust the respiration. In one embodiment, the subject's multi-phase biorhythmic activity is characterized by its respiration rate, and the memory has stored thereon an indication of the initial form and the expected form, the respiration rate in the expected form being different from the respiration rate in the initial form.

For some applications, the two or more phases in the intended form include at least one respiratory phase that is not normally included in the multi-phase biorhythmic activity prior to generating the time-varying stimulus, and the memory has stored thereon an indication of the at least one respiratory phase.

For some applications, the two or more phases in the intended form include at least one respiratory phase selected from a list consisting of breath hold and post-expiration pause, and the memory has stored thereon an indication of the selected respiratory phase.

For some applications, the apparatus includes an impedance load for acting on the subject and preventing airflow from the subject during a selected breathing phase from inspiration and expiration. For some applications, the device includes a mechanical ventilator for acting on the subject and working in conjunction with the stimulation unit.

In one embodiment, the two or more phases of the initial form and the expected form comprise inhalation and exhalation, and the memory has stored therein the initial form and the indication, the ratio of inhalation time to exhalation time in the expected form (I: E ratio) being less than the I: E ratio in the initial form. For some applications, the memory has stored thereon the initial form and the indication, the I: E ratio in the expected form being between 1: 0.5 and 1: 4.

In one embodiment, the apparatus comprises a user interface for receiving input from said subject, and the apparatus is adapted to store an indication of said initial form and said expected form in said memory in response to the input. For some applications, the user interface is to receive an indication of a duration of two or more phases in the indication of expected form.

For some applications, the user interface is to receive an indication of a temporal trend of respective durations of the two or more phases in the initial form.

For some applications, the user interface is to receive an indication of a duration of two or more stages in the initial form. Alternatively or additionally, the user interface is for receiving an indication of a duration of two or more phases in the expected form.

In one embodiment, the user interface is configured to measure a time interval between a start indication and an end indication of at least one phase in the initial form of indication. For some applications, the start and stop indications comprise respective audible indications of breathing of the subject, and the user interface is for detecting the audible start and stop indications. For some applications, the user interface is configured to receive the start and end indications from the object at respective times and to measure the time interval in response to the received indications.

There is also provided, in accordance with an embodiment of the present invention, a method for an object, including:

storing an indication of an initial form of a multi-phase biorhythmic activity pattern and an expected form of the multi-phase biorhythmic activity pattern,

wherein the duration of two phases in the expected form is different from the ratio of the durations of the corresponding phases in the initial form, an

Wherein at least one phase of the multi-phase biorhythmic activity pattern corresponds to a respective phase of one multi-phase biorhythmic activity of the subject;

generating a time-varying stimulus, the time-varying stimulus: (a) substantially unresponsive to ongoing measurement of the multi-phase biorhythmic activity during generation of the time-varying stimulus, and (b) a multi-phase pattern, characterized by a series of transitional forms between the initial form and the intended form that direct the subject to modulate the multi-phase biorhythmic activity.

There is also provided, in accordance with an embodiment of the present invention, a computer software product including a computer-readable medium having stored thereon computer instructions that, when read by a computer, cause the computer to generate a time-varying stimulus that: (a) during generation of the time-varying stimulus, substantially unresponsive to ongoing measurements of the multi-phase biorhythmic activity of the subject, and (b) a multi-phase pattern, characterized by a series of transitional forms between an initial form of the multi-phase biorhythmic activity pattern and an indication of an expected form of the multi-phase biorhythmic activity pattern, the series of transitional forms directing the subject to modulate the multi-phase biorhythmic activity,

wherein at least one phase of the multi-phase biorhythmic activity pattern of the time-varying stimulus corresponds to a corresponding phase of the multi-phase biorhythmic activity, an

Wherein the ratio of the durations of the two phases in the expected form is different from the ratio of the durations of the respective phases in the initial form.

There is also provided, in accordance with an embodiment of the present invention, a data storage medium including a set of data corresponding to an output stimulus for directing the subject to modulate multi-phasic biorhythmic activity of the subject, the stimulus including a time-varying multi-phasic pattern characterized by a series of transitional forms between an initial form of the multi-phasic biorhythmic activity pattern and an expected form of the multi-phasic biorhythmic activity pattern,

wherein at least one phase of the time-varying multi-phase pattern corresponds to a corresponding phase of the multi-phase biorhythmic activity, an

Wherein the ratio of the durations of the two phases in the expected form is different from the ratio of the durations of the respective phases in the initial form.

For some applications, the output stimuli include music. For some applications, the output stimulus includes at least one stimulus selected from the list consisting of an image, alpha-numeric text, a sound pattern, a dynamic graphical pattern, and a visual cue. For some applications, the output stimulus comprises pressure applied to a body part of the subject. For some applications, the output stimulus comprises a massage applied to a body part of the subject. For some applications, the output stimulus comprises mechanical energy applied to a body part of the subject. For some applications, the output stimulus comprises electrical energy applied to a body part of the subject.

There is also provided, in accordance with an embodiment of the present invention, apparatus for an object, including:

a data storage medium comprising a plurality of sets of data, each set of data corresponding to an output stimulus for directing the subject to modulate multi-phasic biorhythmic activity of the subject, the stimulus comprising a time-varying multi-phasic pattern characterized by a series of transitional forms between an initial form of the multi-phasic biorhythmic activity pattern and an expected form of the multi-phasic biorhythmic activity pattern,

wherein at least one phase of the time-varying multi-phase pattern corresponds to a corresponding phase of the multi-phase biorhythmic activity, an

Wherein the ratio of the durations of the two phases in the expected form is different from the ratio of the durations of the respective phases in the initial form; and

a stimulation unit for generating output stimuli corresponding to the selected data set.

Other objects and attainments together with a more complete understanding of the invention will become apparent and appreciated by referring to the following detailed description of the embodiments taken in conjunction with the accompanying drawings in which:

drawings

FIG. 1 is a block diagram of the components of a powered metronome that beneficially modulates a user's biorhythmic activity, according to an embodiment of the present invention;

fig. 2 is a schematic diagram of the metronome of fig. 1 implemented as a dedicated stand-alone device according to an embodiment of the present invention;

FIG. 3 is a schematic diagram of the implementation of the metronome of FIG. 1 as software on a general purpose computer, according to an embodiment of the present invention;

FIGS. 4A, 4B, and 4C are schematic illustrations of a plurality of biorhythmic activity signals in accordance with an embodiment of the present invention;

FIG. 5 is a schematic diagram of transforming biorhythmic patterns during respiratory training in accordance with an embodiment of the present invention;

FIG. 6 is a schematic diagram of a method for defining a new training protocol, in accordance with an embodiment of the present invention;

FIG. 7 is a schematic illustration of dynamic changes over the duration of one phase of a biorhythmic pattern in accordance with an embodiment of the present invention;

fig. 8 is a block diagram of components of the metronome of fig. 1, according to an embodiment of the present invention;

fig. 9 is a schematic diagram of the implementation of the metronome of fig. 1 over a telephone network according to an embodiment of the present invention.

Detailed Description

Fig. 1 is a block diagram of the components of a powered metronome 20 that beneficially modulates the biorhythmic activity of a user 30, according to an embodiment of the present invention. The metronome 20 includes: a User Interface (UI)32, a training definer 34, a driver 36, and a biorhythmic activity modifier 38. The training definer 34 allows the user to define a new training protocol, as will be described below in connection with FIG. 6, or to edit an existing protocol. When the user activates metronome 20 to perform a training protocol, driver 36 creates a training pattern file based on the selected training protocol, as described below in conjunction with fig. 7. Alternatively, the driver 36 retrieves a previously created and stored training pattern file. Driver 36 generates a time series of data from the training pattern file and uses the series to drive biorhythmic activity modifier 38 to generate an output signal to the user, which will be described below in conjunction with fig. 8, to modify biorhythmic activity.

The output signal is typically used to adjust the breathing of the user 30 by training the user to initiate a new breathing pattern. For example, the output signal may instruct the user to change the timing of inspiration and expiration, thereby decreasing the inspiratory-expiratory ratio (I: E ratio). For some interventions, it is desirable to reduce the I: E ratio, for example, from a pre-intervention level of typically 1: 1 or 1: 2 to 1: 4. For some interventions, the new breathing pattern includes additional phases that are not typically found in the conventional, unguided breathing pattern. For example, conventional breathing typically includes two phases: inspiration and expiration. Metronome 20 may be configured to output signals to direct user 30 to add breath hold and/or post-expiration pause phases.

Fig. 2 is a schematic diagram of a metronome 20 implemented as a dedicated stand-alone device 50, according to an embodiment of the present invention. For some applications, the stand-alone device 50 is portable and/or battery-operated. The standalone device may be implemented in dedicated hardware logic or a combination of hardware and software. In the present embodiment, the user interface 32 generally includes a display screen 52 and a plurality of input elements 54, such as buttons, keys or knobs. For example, the input unit 54 may include on/off, enter, up, down, and setup (setup) buttons. For some applications metronome 20 provides the option of setting default values, for example using a set up button. For example, the user may set a default parameter for the number of stages or volume, as will be described in more detail below.

Fig. 3 is a schematic diagram of the metronome 20 implemented as software on a general purpose computer 60 according to an embodiment of the present invention. Software is programmed into the computer 60 to perform the functions described herein. For example, the software may be downloaded to the computer in electronic form, over a network, or supplied to the computer via tangible media, such as magnetic or optical media, or other non-volatile storage, such as CD-ROM. In the present embodiment, the user interface 32 generally includes a keyboard 62 and a monitor 64. For some applications, all or part of the metronome 20 is implemented as a web service, which the user 30 may access over a wide area network, typically the internet. Although the general purpose computer 60 is illustrated in FIG. 3 as a personal computer, this is by way of example and not by way of limitation, and the general purpose computer 60 may also include other computing devices, such as a handheld computing device.

Fig. 4A, 4B, and 4C are schematic diagrams of a plurality of biorhythmic activity signals according to an embodiment of the present invention. These biorhythmic activity signals represent an exemplary bust of the user 30 while breathing is being modulated by the metronome 20. In fig. 4A, line 70 represents the activity signal during the two-phase breathing exercise. Inspiration occurs at phase I and expiration occurs at phase II. In fig. 4B, line 72 represents the activity signal during a three-phase breathing exercise, which includes breath hold during phase III in addition to inspiration and expiration. In fig. 4C, line 74 represents the activity signal during the four-phase respiratory training, which also includes phase IV, during which a post-expiratory pause occurs. Herein, a "biorhythmic pattern" includes two or more phases, and a "biorhythmic activity" includes a sequence of biorhythmic patterns.

Fig. 5 is a schematic diagram of transforming biorhythmic patterns 80 during respiratory training in accordance with an embodiment of the present invention. Metronome 20 is operative to generate and dynamically adjust the multi-phase rhythmic output signal so as to direct user 30 to gradually adjust the onset biorhythmic pattern 80 to the termination biorhythmic pattern 82 via at least one intermediate biorhythmic pattern 84. In the exemplary transformation shown in fig. 5, the biorhythmic pattern includes three phases 86, 88, and 90. For some interventions metronome 20 directs user 30 to adjust different amounts of these stages, and/or only a portion of these stages. In the illustrated example, the metronome directs the user to maintain an initial duration of the stages 86, increase the duration of the stages 88 by a first amount, and increase the duration of the stages 90 by a second amount, where the second amount is greater than the first amount.

For some applications, the number of phases of the initiating biorhythmic pattern 80, the intermediate biorhythmic pattern 84, and/or the terminating biorhythmic pattern 82 is greater than or less than the number of phases of the user's natural biorhythmic pattern. For example, the user's natural biorhythmic pattern has four phases, while the onset biorhythmic pattern 80, the intermediate biorhythmic pattern 84, and/or the termination biorhythmic pattern 82 have only two phases. Alternatively or additionally, two or more phases of the initiating biorhythmic pattern 80, the intermediate biorhythmic pattern 84, and/or the terminating biorhythmic pattern 82 correspond to a single phase of the user's natural biorhythmic pattern. For example, the onset biorhythmic pattern 80, the intermediate biorhythmic pattern 84, and/or the termination biorhythmic pattern 82 may include two sub-phases of inspiration corresponding to a single phase of inspiration of the user's natural biorhythmic pattern.

In one embodiment of the invention, when the user 30 turns on the metronome 20, the metronome lets the user choose to define a new training protocol or to select a protocol from a repository. Typically, metronome 20 automatically shuts down if the user makes no selection for a predetermined time, such as one minute.

FIG. 6 is a schematic diagram of a method for defining a new training procedure, according to an embodiment of the invention. In a type selection step 100, the user 30 selects a procedure of the "termination" type or the "trend" type in order to start defining a new training procedure. The "termination" type procedure enables the user to define parameters for initiating and terminating the biorhythmic pattern, as will be described later, and the "trend" type procedure enables the user to define parameters for initiating the biorhythmic pattern and trends for initiating the various phases of the biorhythmic pattern, as will be described later. The user 30 makes this selection and other selections using the user interface 32, for example, using up and down buttons for scrolling options and an enter button to make the selection.

In an end/trend detection step 102, metronome 20 checks which type of protocol user 30 has selected. If the user selects an "end" type of procedure, metronome 20 prompts the user to enter the expected number of stages to initiate the biorhythmic pattern, at an initial stage number selection step 104. The metronome also prompts the user to enter an expected number of stages to terminate the biorhythmic pattern, at a termination stage number selection step 106. For some applications metronome 20 does not provide the option of selecting the number of different stages to initiate and terminate the biorhythmic pattern, and therefore, steps 104 and 106 are combined to prompt the user to enter a single number of stages to initiate and terminate both biorhythmic patterns.

In an initial parameter setting step 108, the user 30 sets parameters that initiate the various stages of the biorhythmic pattern. The user typically, but not necessarily, attempts to set these parameters according to the user's current spontaneous breathing pattern, i.e. prior to treatment using the currently defined protocol. (for example, the user may also arbitrarily set a starting parameter indicating a time faster than the user's spontaneous breathing pattern). For some applications, the user enters the duration of each available phase (typically in seconds) using the numeric input tool of the user interface 32. For phases that do not occur during the user's spontaneous breathing pattern, e.g., breath hold and/or post-expiration pause, the user typically enters a 0. Alternatively, the user may indicate the duration of each available phase by indicating in real time the beginning and end of each phase during self-observation (self-observation) of his or her breathing pattern (e.g., by pressing one or more buttons). Metronome 20 measures the interval between the start and end indications, for example using a built-in clock, to determine the duration of the selected phase. For some applications, metronome 20 generates a click to assist the user in defining the stage in step 108. Still alternatively, the user interface 32 may include a microphone to detect the user's spontaneous breathing patterns and determine the timing of these phases in real time. (note: metronome 20 typically performs such breathing detection only during the defined training protocol, rather than during training using a metronome). Other methods of expressing the starting parameters will be apparent to those skilled in the art upon reading this patent application.

In the termination parameter setting step 110, the user 30 sets parameters for terminating the respective stages of the biorhythmic pattern. For example, the user may determine these parameters based on a manual guide accompanying metronome 20, recommendations from a health care provider or training instructor, or personal experience with the metronome. The termination parameter may be set using the method described in step 108 for setting the start parameter. To use the described real-time method, the user temporarily actively controls his or her breath to mimic the expected termination biorhythmic pattern.

For some applications, the user may select the type of synthetic instrument to be used at various stages during training in steps 108 and/or 110, which will be described in more detail below in conjunction with FIG. 8. Alternatively or additionally, the user may select which song to use during the workout, i.e., a combination of music phases. Such a selection is typically made during the definition of the training protocol or during training using a metronome. For some applications, the user makes this selection using a setup button.

For some applications, metronome 20 continuously outputs stimuli representing the parameters selected by the user for the currently defined stage as the user defines the training protocol in steps 108 and 110. To output this stimulus, metronome 20 activates driver 36 to drive biorhythmic activity modifier 38, which will be described later in conjunction with fig. 8. The immediate feedback may generally assist the user in defining the parameters.

In an adjust period duration setting step 112, the user 30 uses the user interface 32 to set the duration of a period during which the metronome dynamically changes the output signal to drive the transition from the initiating biorhythmic pattern to the terminating biorhythmic pattern during a training session using a defined training protocol. Alternatively, the user may also set the total duration of the training protocol in the protocol duration setting step 114. The total duration must not be less than the adjustment period duration. If the total duration is greater than the conditioning cycle duration, then after the termination of the biorhythmic pattern is reached, the metronome maintains the termination of the biorhythmic pattern for a period of time during the training period equal to the difference between the total duration and the conditioning cycle.

Regulator 20 then saves the defined training protocol in a save protocol step 116. The metronome 20 typically causes the user 30 to immediately initiate a training session using a newly defined training protocol, as will be described in more detail below.

However, if the user 30 selects the "trend" type in the checking step 102, the metronome prompts the user to enter the expected number of stages to initiate the biorhythmic pattern in an initial stage number selection step 118. In an initial parameter setting step 120, the user 30 sets parameters for initiating the phases of the biorhythmic pattern using the method described in step 108. In the set trend step 122, instead of setting the parameters for terminating the biorhythmic pattern as described above for the "termination" type of procedure, the user sets the trends for the respective initial stages. For some applications, these trends indicate a percentage change in the respective duration of each initial phase, e.g., extending each phase by a certain percentage over each respiratory cycle or over a given period, e.g., every minute. Of course, the same proportional changes may be made to the initial stages. For some interventions, the user indicates an absolute change to the respective duration of each initial phase, for example extending each phase by a certain number of seconds within a given period, such as every minute. In a procedure duration setting step 124, the user 30 sets the total duration of the procedure. The method then proceeds to step 116 where the metronome saves the protocol.

Alternatively, the training definer 34 may provide the user with other methods of defining the training protocol. For example, the user may select the initial biorhythmic pattern using one of the methods described above. The user then selects the desired improvement metric to be achieved in terminating the biorhythmic pattern, for example from a menu. For example, the user may select: (a) an expected ratio of starting to ending breath rates; (b) an expected end ratio of inspiration to expiration (I: E ratio); and/or (c) the expected improvement in I: E ratio. Other methods of causing the user to select the desired and/or appropriate termination of the biorhythmic pattern will be apparent to those skilled in the art who have read this patent application.

In an embodiment of the present invention, the user interface 32 of the metronome 20 presents the user with a menu of available exercises (typically scrolling) including key parameters for each exercise. As described above in connection with fig. 6, the available training may be defined by the user, preprogrammed or loaded into the device, e.g. via a communication network. The following table shows a portion of a schematic menu of available exercises:

in this menu, the number of values provided for the start and stop modes corresponds to the number of stages of training, and the "adjust" column includes the length of the adjustment period, which has been described above in connection with step 112 of FIG. 6.

In one embodiment of the present invention, when the user 30 selects a training protocol, the driver 36 creates a training pattern file based on the selected training protocol. Alternatively, the driver 36 retrieves a training pattern file previously created and stored for the selected training protocol. To create the training pattern file, the driver 36 uses one or more linear or non-linear algorithms. The training pattern file typically includes a record of each biorhythmic pattern in the sequence of biorhythmic line patterns that varies over the training period. The first and last records hold information about the start and stop biorhythmic patterns, respectively, and the remaining records hold information about each intermediate biorhythmic pattern. Each record includes a phase value for each phase of the biorhythmic pattern, the phase value representing a duration of the phase. If the number of phases that start and stop the biorhythmic pattern is different, each record includes a number of phase values equal to the larger number of phases (typically, the undefined phase of a given record is represented by 0).

In one embodiment of the present invention, the driver 36 uses the following algorithm for calculating the phase values for each record in the training pattern file according to the "termination" type procedure described above with reference to FIG. 6. Each record includes N phase values of 1 … … N, where N is equal to the number of phases having a greater number of phases to start or stop the biorhythmic pattern. Total duration T of each biorhythmic pattern j_jPhases T equal to pattern j_j[1]……T_j[N]The sum of the durations of (c) is as follows:

the following formula gives the number of records n to be played in the training mode file:

n＝INT[(duration)/(T_start+T_end)/2]

where INT is the rounding function and duration is the duration of the conditioning period, as described above in connection with FIG. 6, T_startAnd T_endThe total duration of the initiation and termination of the biorhythmic pattern, respectively.

The duration of any given phase k of a biorhythmic pattern j is represented by the following equation:

T_j[k]＝T_start[k]+j*ΔT[k]

wherein the content of the first and second substances,

ΔT[k]＝(T_end[k]-T_start[k])/n

for example, the initial biorhythmic pattern and the termination biorhythmic pattern may each have two phases. The duration of each phase of the initial biorhythmic pattern may be 1 second and 2 seconds, respectively, and the duration of each phase of the terminated biorhythmic pattern may be 2 seconds and 6 seconds, respectively. The duration of the conditioning period may be 555 seconds. Thus:

T_start1+2 seconds to 3 seconds

T_end2+6 seconds 8 seconds

n＝INT(555/((3+8)/2))＝INT(100.9)＝100

Δ T [1] ═ 0.01 second (2-1)/100 ═ 0.01 second

Δ T2 ═ 0.01 sec (6-2)/100 ═ 0.01 sec

Thus, the first phase has a duration sequence of 1.00, 1.01, 1.02, … …, 1.99, 2.00 (101), and the second phase has a duration sequence of 2.00, 2.04, 2.08, … …, 5.96, 6.00 (101). The actual duration of the conditioning cycle is 100 x (3+ 8)/2-550 seconds, slightly less than the programmed 555 seconds. When the output signal comprises music, the number of recordings is rounded to an integer, thereby preventing premature ending of the music in the middle of the mode, which would otherwise be very unattractive.

Typically, driver 36 sets T for each phase k that is included in the initial biorhythmic pattern but not included in the termination biorhythmic pattern_end[k]0. Likewise, for each phase k included in the termination biorhythmic pattern but not included in the initiation biorhythmic pattern, driver 36 sets T_start[k]＝0。

Alternatively, the driver 36 determines the various durations by using an algorithm using a geometric series or other series employing techniques known to those skilled in the art. Still alternatively, driver 36 uses an algorithm that changes the ratio of biorhythmic patterns (i.e., the inverse of the duration).

In an embodiment of the present invention, the driver 36 uses the following method for calculating the phase values of the records in the training pattern file according to the "trend" type procedure described with reference to FIG. 6. During the duration of the protocol, driver 36 calculates the ratio of each phase k (i.e., the reciprocal of the duration) of each biorhythmic pattern j using the following equation:

1/T_j[k]＝(1-e[k])*(1/T_j-1[k])

wherein e [ k ]]Is a selected change of each biorhythmic pattern of phase k, 1/T_j[k]Is the ratio of the biorhythmic pattern j.

Reference is now made to fig. 7, which is a schematic illustration of an exemplary dynamic variation of a duration of a phase of a biorhythmic pattern in accordance with an embodiment of the present invention. Line 150 represents a schematic variation in the duration of a single phase of a series of biorhythmic patterns that begins with an initial biorhythmic pattern, passes through an intermediate biorhythmic pattern, and ends with a terminating biorhythmic pattern.

Reference is now made to fig. 8, which is a block diagram of the structure of driver 36 and biorhythmic activity modifier 38, in accordance with an embodiment of the present invention. The driver 36 includes a training memory 160 and a pattern code memory 162. The training memory 160 includes: (a) a training pattern file storage 164 in which training pattern files created as described above with reference to fig. 7 are stored; (b) a training protocol memory 166 in which training protocols are stored, either created as described above with reference to fig. 6, or pre-programmed or loaded into the metronome 20.

Driver 36 also includes a sequencer 168 that generates a time code and passes this time code to biorhythmic activity modifier 38 during the execution of the training protocol by driver 36. Sequencer 168 retrieves the training pattern file from pattern file storage 164, retrieves the pattern codes from pattern code storage 162, and combines the information from the training pattern file with the pattern codes to produce a time code as described below. When the sequencer generates a time code, sequencer 168 typically performs such an acquisition when a training protocol is initiated or throughout the training protocol.

For applications where the output signal comprises music, the pattern code contains elements of music information representing the various phases of the various biorhythmic patterns of the selected training pattern file, such as notes (notes) and/or types of synthetic instruments. For example, a two-stage training pattern has two synthesized instrumental sounds a and B, corresponding to the first and second stages, respectively. The pattern code has a structure A₁、B₁、A₂、B₂、A₃、B₃… …, wherein A_iAnd B_iEach representing a series of musical notes associated with one or more synthetic instrument sounds. And A_iAnd B_iThe associated instrument sounds may or may not be the same.

Continuing the two-phase example, A_iRepresenting a series of notes to be produced by a synthetic flute sound, and B_iRepresenting a series of notes to be produced with a synthetic horn and violin sound. The training pattern may comprise a biorhythmic pattern comprising a phase 1 of 2 seconds long followed by a phase 2, a of 4 seconds₁Can represent a seriesTwo whistling notes, and B₁Representing a series of two horn sounds followed by a violin sound. Sequencer 168 compares the information of phase 1 and phase 2 of the biorhythmic pattern with A of the pattern code₁And A₂Are combined separately, resulting in a temporal code. The time coding includes: an ON signal of series a1, 2 seconds later followed by an OFF signal of series a1 and an ON signal of series B1, 4 seconds later followed by an OFF signal of series B1, etc.

Referring again to fig. 8, biorhythmic activity modifier 38 includes: a pattern generator 170 and a stimulus generator 172. The pattern generator 170 converts the time code into a signal that drives the stimulus generator 172. For some applications, the pattern generator 170 includes a sound synthesizer and the stimulus generator 172 includes one or more speakers 40 (fig. 2, 3 and 9), in which case the pattern generator 170 time-codes the music into currents that drive the speakers to create sound.

Alternatively, the stimulus generator 172 includes:

● A visual stimulator, such as a display, may include a digital display screen and/or one or more notification lights. Display screen 52 (FIG. 2) or monitor 64 (FIG. 3) may be configured as a visual display screen;

● A pressure applicator, such as a pressure cuff 174 (FIG. 2) mounted on an arm 176 of the user 30, is configured to massage the arm for some applications. The pattern code includes ON and OFF signals that biorhythmic activity modifier 38 converts into electrical signals to drive a pump (not shown) that evacuates and inflates cuff 174;

● A mechanical stimulator; and/or

● an electrical stimulator.

In one embodiment of the invention, the user stimulus is in the form of a game and parameters of the game may be modified so that the user may adjust parameters of the biorhythmic activity by playing the game.

Reference is now made to fig. 9, which is a schematic illustration of a metronome 20 implemented over a telephone network 200, according to an embodiment of the present invention. In this embodiment, the stimulus generator 172 typically comprises a speaker 202 of a conventional wired or wireless telephone 204, and the user interface 32 comprises a keypad 206 of the telephone. Other components of metronome 20 are implemented remotely from user 30, such as at a telephone company or at another service provider. The telephone 204 is connected to such a remote metronome function device 210 wirelessly or through a telephone line, typically through at least one telephone switch 212. Alternatively, the user interface 32 includes a microphone 208 of the telephone 204 that functions to interpret user 30 voice commands and/or to program the metronome 20 to detect the breathing of the user 30, as described above with reference to fig. 6.

In one embodiment of the present invention, the metronome 20 is implemented using dual tone multi-frequency (DTMF) signals generated by the user using the keypad 206 through the telephone network 200 and decoded by the remote metronome function device 210. The following table shows an exemplary implementation of the system. It will be understood by those skilled in the art that the details of this table are given for illustrative purposes only and that many other alternatives will be apparent to those skilled in the art upon reading the present application.

Step # of	User actions	System actions
			1	Calling service number	And (3) voice: "welcome to 'breathe with us' service, please enter your personal code. "
2	Entering personal codes	And (3) voice: "choose your previous training, press 1; choose a new training, please press 2; listen to the demonstration, please press 3; selecting sound, please press 4 at any time; ask for help, please press 111 at any time; continuing to a step, please press the number key at any time; returning to the previous step, please press the star key at any time; quit, please press 0 at any time. "
			3	In response to step 2 by 1	And (3) voice: please type in a training number or press 11 to receive

		Listen to the list (scroll using the number sign and asterisk keys). "
			4	Inputting training numbers in response to step 3	The system goes to step 19.
5	In response to step 3 pressing 11	And (3) voice: "choose a training from the list, please press 1; delete training, please press 999; training #1 included: reducing the respiration from 15 breaths per minute with a 1: 2 inhaling-to-exhaling ratio of 6 breaths per minute with a 1: 4 inhaling-to-exhaling ratio; choose, please press 1 "; [ Stop FOR PERIOD ] "TRAINING #2 … …"
			6	In response to step 5, a training is selected by pressing the corresponding number,	the system goes to step 19.
7	In response to step 2, press 2	And (3) voice: "select a breathing pattern including inspiration and expiration, please press 21; selecting a breathing pattern comprising inspiration, breath hold, and expiration, please press 22; the breathing pattern of inspiration, breath hold, expiration and rest is selected, please press 23. "
			8	In response to step 7 pressing 21	And (3) voice: please press the number key when starting to inhale; then, when the expiration starts, pressing the number key; finally, when starting new inspiration, pressing the number key. "
9	In response to step 8, at the beginning/end of each phase, the number of well key is pressed	At one second intervals, the sounds are counted 1, 2, 3, 4 … … and are re-counted at the beginning of each phase. After completion, speech: "you have selected _ inspiration and _ expiration; always playing your selectionMode until you press down the well

		Number key. The system uses a default music play mode.
			10		And (3) voice: "choose your target breathing pattern, press 200; choose to change trend, please press 210. "
11	In response to step 10 press 200	The system uses the process of steps 8-9 and then goes to step 17.
			12	In response to step 10 press 210	And (3) voice: please enter the proportion by which you wish to increase the duration of each inspiration from one breath to another, typically 5% to 15%. "
13	Input ratio	And (3) voice: "please input your willThe proportion by which the duration of each exhalation is expected to increase from breath to breath is typically 5% to 15%. "
			14	Input ratio	And (3) voice: please enter for a few minutes you want to make a change in your breathing pattern. "
15	Input duration	The system calculates the termination pattern, converts it to the closest "count structure", describes its structure in step 9, and plays the termination pattern using default music until the pound key is pressed.
			16	Responsive to step 15 pressing the number of well key	And (3) voice: please enter additional minutes to continue after termination mode, if not, please press the number of well key. "
17	Inputting additional minutes or pressing number keys	And (3) voice: "save training, please press 50; start training, please press the number key; exit, please press 0. "
			18	In response to step 17 pressing 50	And (3) voice: "train on date" is saved as number [ xxx ]. The system goes to step 17.
19	Responding to step 17 by pressing number key	And (3) voice: please enjoy training. If you want to know how much time remains, please press 1 at any time. "system calculation training mode file or determination memory

		A suitable sequence. The system starts the sound system and plays the music stimulus. When the time limit is exceeded, speech: thank you breathe with us. The system ends the method.
			20	In response to step 19, press 1	Voice-over provides the remaining time.
21	At any time press 4	And (3) voice: "please select your favorite music from the list, press the number of a well key to scroll through the available options, and press the number of a well key to return; exit and hold the sound, please press 1. The system goes to step 2.
			22	In response to step 21, press 1	The sound of a music title, such as "bamboo dance", is presented. The "system uses the selected music,the initial mode is played. The system goes to step 2.
23	In response to step 2, press 3	And (3) voice: "this is a demo demonstrating to you the power of the 'breathe with us' service. "the system plays a sample, and voice-over explains its main features. The system goes to step 2.

Reference is again made to fig. 2, 3 and 9. In one embodiment of the present invention, the metronome 20 includes: (a) a library of training output signals comprising music generated by biorhythmic activity modifier 38 using a plurality of respective predefined training protocols; (b) means for playing music stored in the library. For some applications, the metronome 20 comprises a conventional music player, such as a CD player or tape player (portable configuration is shown in fig. 2), with the music stored on a non-volatile medium, such as a CD or audio tape. Alternatively, the metronome 20 comprises conventional audio software (fig. 3) or metronome function 210 (fig. 9) running on the computer 60, in which case the music is either stored on a non-volatile medium such as a CD or DVD, or stored in memory after being downloaded, for example, over the internet. For some applications, the music is represented using a Musical Instrument Digital Interface (MIDI) protocol, and software on the computer 60 or the metronome function 210 interprets the MIDI information to synthesize the music. Typically, each training in the library is identified by parameters, or a subset thereof, that define the training protocol on which the training is based (such parameters are as described in fig. 6).

In this embodiment, the user 30 selects a workout, i.e. a piece of music, from the library using the user interface 32. For some applications, user interface 32 is configured as described above with reference to a table showing a portion of an exemplary menu of available exercises. Alternatively, the user interface 32 comprises a conventional user interface of a conventional music player or conventional audio software, where appropriate. In such a configuration, the names of the pieces of music typically include one or more key parameters for training. For example, a piece of music based on a two-phase training protocol with 20 breaths per minute (bpm) at the beginning and a 1: 1 call-in ratio at the end of 6bpm and an I: E ratio of 1: 3 may be named "Song 5/from 20bpm, a ratio of 1: 1 to 6bpm, a ratio of 1: 3. Or, instruct the user to count his or her breath number within a set period of time, for example, 1 minute, and select a piece of music having a number corresponding to the breath number.

Typically, the exercises included in the library are selected so as to provide the user 30 with a sufficient variety of options, while the total number of selections is usually limited. Such limiting of the selection may reduce the amount of storage required by the library and/or increase efficiency and/or facilitate user selection of desired training.

In one embodiment of the invention, the training included in the library may be selected to provide options for important termination parameters, such as the number of termination phases, the termination bpm, and the termination I: E ratio. Typically, there are few starting parameter options, or only a single option. This lack of options generally does not inconvenience the user as long as the selected starting parameter is in the normal breathing pattern of most users. For some applications, the starting bpm is faster than most users 'natural bpm, for example 20bpm, and the user is instructed to fast-forward to a point in the selected piece of music where the bpm has dropped to the user's current bpm. The total number of changes typically results in storing some music, which can be stored, for example, on only one, two or three conventional CDs.

For example, the library includes training based on the following parameters:

● initial parameters: (a)20 bpm; (b) the ratio of I to E is 1: 1; and

● termination parameters: (a)10, 6 or 4 bpm; (b) the two-stage I: E ratio is 1: 2, 1: 3 or 1: 4, or the three-stage I: E ratio is 1: 1, 1: 3 or 2: 1: 2.

Alternatively or additionally, for some interventions, the library includes training to adjust the user's I: E ratio without having to change the breathing rate. For example, the training may have a constant bpm of 10, and the I: E ratio may begin at 1: 1 and end at 1: 4 after 10 minutes. Such training is beneficial for those users with respiratory ailments.

In one embodiment of the present invention, metronome 20 stores a limited number of exercises as musical pieces or training pattern files. The metronome 20 provides the user 30 with the option of defining the desired training protocol, as described above in connection with fig. 6. However, during the rest period, the metronome 20 does not generate music or training pattern files according to the circumstances, but selects pieces of music or training pattern files that are stored in advance and that are very similar to the desired procedure according to the circumstances. Alternatively, the metronome may be configured to: depending on the situation, at a point after the start, playing of pre-stored music or interpretation of pre-stored training pattern files is started, thereby better matching the training protocol desired by the user. For example, if the starting parameters of the user-selected protocol include 1.02 seconds of inhalation and 2.1 seconds of exhalation, and the metronome has stored the exemplary 550 second two-phase training pattern file described above, then the metronome may begin training using the third pattern in the stored time series. If the selected parameter fails to exactly match one of the stored patterns, the metronome typically selects the stored pattern that matches closest to the selected parameter.

Metronome 20 is suitable for many applications, including those described in the following table:

applications of	Configuration of metronome 20	Operation of
			The treatment mode comprises the following steps: effecting a slow exhalation with extended exhalation from normal breath	As described herein	As described herein
Treating a patient with Chronic Obstructive Pulmonary Disease (COPD) by: during inspiration, the breath is retrained with a resistive load, thereby achieving a specific inspiration/expiration time ratio	The method comprises the following steps: (a) resistance load to prevent airflow during inspiration (or expiration); and/or (b) additional memory to record the date and time of use of the device, thereby enabling healthcare	A specific termination pattern is to be implemented, such as: 15 breaths per minute with an inspiration time of 2.5 seconds and an expiration time of 1.5 seconds, or a health care professional or training finger

Target frequency	Professional assessment of compliance with usage guidelines	Each recommended breath by the instructor
			The treatment mode comprises the following steps: physical exercise including physical movement and respiration	The method comprises the following steps: tactile stimulation to guide breathing; auditory stimuli for directing other body movements. Typically using the embodiment shown in FIG. 2	For example, the hand is raised four beats (stages 1 to 4) and lowered two beats (stages 4 to 6). At the same time, the "inhalation" vibration stimulus is applied during phases 1 to 4
The treatment mode comprises the following steps: training dysfunctional muscle tissue	Including electrodes for stimulating muscles
			Obtaining an "at home" indication from a mentor (e.g., a yoga trainer) who defines traditional classroom training
Independent system for regulating movement in physical exercise	For example, it includes: watch worn on the hands of a trainer participating in aerobic fitness or other types of training with multi-stage training
			Finger independent massage system using pressure stimulation	Comprising a pressure applicator
PC-based relaxation system in workplace	Only software, auditory-visual stimuli, all required hardware platforms already exist

In one embodiment of the present invention, metronome 20 performs the intervention by generating a user stimulus that causes user 30 to react unintentionally. Typically, such unintentional user stimulation is somewhat incompatible with biorhythmic activity such as respiration that it is desired to regulate when applied. This method may be used, for example, when the user is an object whose breathing control is impaired, such as an unconscious object (e.g., the object is in a coma or anesthesia). Furthermore, the method may be used when the user is sleeping, such as when the user is sleeping apnea due to the user not having sufficient control over breathing. For example, the intervention may stimulate the respiratory muscles of an unconscious, but instinctively breathing user through auditory or other stimulation. Furthermore, the method may also be used when the user is mechanically breathing.

Even when an intervention is applied to a conscious user, for some applications the user may semi-consciously or unconsciously regulate some aspect of spontaneous activity. For example, many people unconsciously and effortlessly coordinate their breathing, pace or running with external rhythmic stimuli such as strong rhythmic music or even flashing lights. Also, some embodiments of the invention may be useful for those who are unconsciously attempting to coordinate their spontaneous movements with the rhythm of the applied intervention. Thus, for some applications, the user in such embodiments may act on the user to intervene as described above while reading, chatting, eating, or even sleeping. For example, an application running in the background of a user's personal computer may play a music pattern while the user is working.

In one embodiment of the present invention, metronome 20 instructs user 30 to change his or her breathing pattern in a manner that generally increases tissue oxygenation. The invention is particularly useful in the treatment of Congestive Heart Failure (CHF), which often results in patients exhibiting tidal breathing. This breathing pattern results in a reduction in average tissue oxygenation because breathing too slowly does not provide sufficient oxygen to the body, while vigorous breathing places a heavy burden on the patient's otherwise weak heart and does not optimally supply oxygen to the body. Typically, the musical patterns include musical or vocal guidance that allows the user to inhale and exhale according to a schedule to gradually bring his or her breath into a desired healthy pattern to provide tissue oxygenation. According to one embodiment of the present invention, the protocols described in the Mortara and Bemard articles cited above use the techniques described herein to achieve the desired increase in tissue oxygenation. For example, inspiratory musical instruction and vocal instruction include a flute sound playing a series of notes, the flute sound generally increasing in pitch and/or volume, while expiratory instruction includes cello and guitar notes, the pitch and/or volume of which is decreasing. Alternatively, the user is instructed to inhale at the beginning of the training session as long as he hears a flute sound or tone having a particular high pitch, and to exhale as long as he hears a cello, guitar, or tone having a particular low pitch. Protocols for producing music are described in the previously referenced U.S. patent application 09611304 and' 049 PCT publication, see fig. 16 thereof for details.

Alternatively or additionally, the metronome 20 is operated so as to increase the mechanical compliance of the user's blood vessels. This compliance reflects the ability of the vessel to dilate in response to the passage of blood exiting the heart (passage). It is well known that a sufficient level of arterial compliance can buffer the pulsatile pattern of blood pushed from the high pressure of the heart, thereby smoothing blood flow into the microvasculature. In contrast, reduced arterial compliance is linked to abnormal function of baroreceptors, which are used by the body in the feedback system of control blood pressure. It is known that arterial compliance decreases with age and in many cardiovascular diseases such as hypertension, CHF and atherosclerosis. In addition, arterial compliance decreases in response to a sharp increase in blood pressure and in response to increased sympathetic activity, for example, when psychological stress is present in the user. Alternatively or additionally, the metronome 20 is operated so as to reduce the peripheral resistance of the user's small blood vessels to increase the user's heart rate variability and/or to increase the user's sensitivity to baroreflex.

Metronome 20 typically increases arterial compliance in a manner similar to that described for increasing blood oxygenation. The inventor finds that: many cardiovascular metrics can be optimized by adjusting the user's breathing rate or other spontaneous or non-spontaneous physiological parameters to a period of about 6 repetitions per minute.

In the case of patients with COPD, the skilled person will know that: the patient may be instructed to increase breath hold by using an inspiratory load to breathe 15 times per minute while using 60% of each respiratory cycle for inspiration and 40% for expiration. Since such training requires a high degree of mental and physical effort, and because of the relatively cumbersome nature of this task, most patients have difficulty adhering to such therapy without the use of metronome 20, and even some patients tend to stop exercising except under the direct supervision of a health care worker.

In one embodiment of the present invention, metronome 20 comprises a sensor for detecting physiological events of subject 30. Metronome 20 typically determines the initial biorhythmic pattern parameters when an event is detected, at least partially in response to signals generated by the sensor. For example, the event may be a segment of abnormal breathing, such as sleep apnea, in which case the sensor detects a cessation of breathing, a sudden change in heart rate, or other indication of apnea. After abnormal breathing is detected, metronome 20 initiates the multi-stage audio, electrical, or other stimuli described herein in an attempt to restore normal breathing. For some applications, metronome 20 monitors one or more physiological variables, such as pulse beat or respiration, and analyzes these variables to determine the duration of the phase that initiates the biorhythmic pattern, almost continuously, prior to initiating stimulation. Typically, a library of stimuli is provided and metronome 20 uses stored patterns or algorithms to select the most effective corresponding onset biorhythmic pattern and trend or termination parameters. Alternatively, the metronome sets the initial biorhythmic pattern in response to abnormal breathing patterns detected during an apnea. Generally, a stimulus is applied to a subject suffering from sleep apnea, in accordance with an initial biorhythmic pattern, mimicking the spontaneous respiratory control sometimes required for restoring normal breathing.

In contrast, in some embodiments of the invention, there may be substantially no bother, as the user 30 need only listen to music, breathing according to tempo and pattern. In addition, this embodiment provides more functionality, such as a "sniff light," which has a 60% duty cycle, which is turned on 15 times per minute. In contrast, metronome 20 typically gradually changes the user's breathing pattern from an initially measured or estimated state (e.g., 8 breaths per minute, 30% inspiration, 70% expiration) to a desired final state. Typically, this change is accomplished by guiding the user to breathe using a two-dimensional parameter space defined by { [ breathing rate ], [ breathing ratio ] }. Metronome 20 typically directs the user's breath from a point in space representing an initial state, along a path in space (e.g., the shortest path through space), to a point in space representing a desired final state.

It is well known that some patients have a slow recovery of their respiratory system after surgery and others take days or weeks to successfully disengage the mechanical ventilator. Accordingly, with the necessary modifications, some applications of the present invention use the apparatus and methods described herein to retrain ventilator-dependent patients or post-operative patients in accordance with appropriate breathing protocols. Many mechanical ventilators for awake (alert) patients are triggered to support the patient's breathing effort, rather than specifying the time and depth of each breath. In the embodiment of the invention that is free of ventilators, where the user exercises active control over his/her breathing, a patient-triggered ventilator is typically used in conjunction with the metronome 20.

The methods described herein may be used in conjunction with the techniques described in U.S. patent application 09611304 and the' 049 PCT publication.

It will be appreciated by those skilled in the art that although embodiments of the present invention have been described above, sometimes with respect to a sick user, the option of using aspects of the present invention for a generally healthy user to achieve psychological stress relief and/or relaxation, or for muscle re-education, exercise training or entertainment, is also covered by the scope of the present invention.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove, but that the scope of the invention includes both combinations and subcombinations of the various features described hereinabove (subembodiments) as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.

Claims (55)

1. Apparatus for use with a subject, comprising:

a memory for storing a set of computer instructions,

wherein the memory has stored thereon an indication of an initial form of the multi-stage biorhythmic activity pattern and an expected form of the multi-stage biorhythmic activity pattern,

wherein the ratio of the durations of the two phases in the expected form is different from the ratio of the durations of the corresponding phases in the initial form,

wherein at least one phase of the multi-phase biorhythmic activity pattern corresponds to a respective phase of one multi-phase biorhythmic activity of the subject;

a stimulation unit for executing the stored instructions and producing a time-varying stimulus in response to execution of the instructions, said time-varying stimulus: (a) substantially unresponsive to ongoing measurements of the multi-phase biorhythmic activity during generation of the time-varying stimulus; (b) there is a multi-phase pattern characterized by a series of transitional forms between the initial form and the intended form that direct the subject to modulate the biorhythmic activity.

2. The apparatus of claim 1, wherein the stimulation unit is to generate a time-varying stimulation having the multi-phase pattern, wherein durations of transition forms in the series vary linearly in time.

3. The apparatus of claim 1, wherein the stimulation unit is to generate a time-varying stimulation having the multi-phase pattern, wherein durations of the transitional forms in the series geometrically vary in time.

4. The apparatus of claim 1, wherein the initial form has a first number of stages and the expected form has a second number of stages, the first number not equal to the second number, and wherein the memory has stored thereon an indication of the initial form and the expected form having a different number of stages.

5. The apparatus of claim 1, wherein the initial form has a greater number of phases than the expected form, and wherein the memory is to indicate a phase in the expected form that is present in the initial form but not present in the expected form by setting a duration of the phase equal to 0.

6. The apparatus of claim 1, wherein the expected form has a greater number of phases than the initial form, and wherein the memory is to indicate a phase in the initial form that is present in the expected form but not present in the initial form by setting a duration of the phase equal to 0 in the initial form.

7. The apparatus of claim 1, wherein the initial form and expected form have a same number of phases, and wherein the memory has stored thereon an indication of the initial form and the expected form having a same number of phases.

8. The apparatus of claim 1, wherein the memory has stored thereon an indication of the initial form and the expected form prior to use of the apparatus by the subject.

9. The apparatus of claim 1, wherein the time-varying stimulus comprises at least one stimulus selected from the list consisting of an image, alpha-numeric text, a sound pattern, a dynamic image pattern, and a visual cue, and wherein the stimulus unit comprises a visual stimulator for generating the selected time-varying stimulus.

10. The apparatus of claim 1, wherein the time-varying stimulus comprises pressure, and wherein the stimulation unit comprises a pressure applicator for applying pressure to a body part of the subject.

11. The apparatus of claim 1, wherein the time-varying stimulation comprises massage, and wherein the stimulation unit comprises a massage device for massaging a body part of the subject.

12. The apparatus of claim 1, wherein said time-varying stimulation comprises mechanical energy, and wherein said stimulation unit comprises a mechanical stimulator for applying the mechanical energy to a body part of said subject.

13. The apparatus of claim 1, wherein said time-varying stimulation comprises an electrical current, and wherein said stimulation unit comprises an electrical stimulator for applying the electrical current to a body part of said subject.

14. The device of claim 1, wherein the time-varying stimulus is in the form of a game, and wherein the stimulus unit comprises a game generator for changing a parameter of the game, thereby directing the subject to modulate the multi-stage biorhythmic activity.

15. The apparatus of claim 1, wherein the stimulation unit is to transmit the time-varying stimulation to the subject over a telephone network.

16. The apparatus of claim 1, wherein the stimulation unit is configured to transmit the time-varying stimulation to the subject over a wide area network.

17. The apparatus of claim 1, comprising a muscle stimulator for working in conjunction with the stimulation unit and applying an electrical current to a muscle of the subject configured to stimulate the muscle.

18. The apparatus of claim 1, wherein the stimulation unit is to configure the time-varying stimulation to increase tissue oxygenation of the subject.

19. The apparatus of claim 1, wherein the stimulation unit is to configure the time-varying stimulation to improve mechanical compliance of the subject's blood vessel.

20. The apparatus of claim 1, wherein the stimulation unit is to configure the time-varying stimulation to reduce peripheral resistance of small blood vessels of the subject.

21. The apparatus of claim 1, wherein the stimulation unit is to configure the time-varying stimulation to increase heart rate variability of the subject.

22. The apparatus of claim 1, wherein the stimulation unit is to configure the time-varying stimulation to increase a baroreflex sensitivity of the subject.

23. The device of claim 1, comprising a movement stimulator for working in conjunction with the stimulation unit and generating a movement stimulus that directs the subject to move the subject's body limb.

24. The apparatus of claim 1, wherein the stimulation unit is to generate the time-varying stimulation when the subject is sleeping.

25. The apparatus of claim 1, wherein the stimulation unit is to generate the time-varying stimulation when the subject is mechanically breathing.

26. The apparatus of any one of claims 1 to 25, wherein the time-varying stimulus comprises music.

27. The apparatus of claim 26, wherein: the stimulation unit comprises a music synthesizer for generating the music.

28. The apparatus of any one of claims 1 to 25, wherein the stimulation unit is adapted to generate a time-varying stimulus which is substantially unresponsive to ongoing measurements of the physiological variable of the subject during generation of the time-varying stimulus.

29. The apparatus according to claim 28, wherein said stimulation unit is adapted to generate a time-varying stimulus which is not responsive to a measurement of a physiological variable of said subject during use of the apparatus by said subject.

30. The device of any one of claims 1 to 25, comprising a sensor for detecting a physiological event and generating an event signal in response thereto,

wherein the device is adapted to receive the event signal before the stimulation unit generates the time-varying stimulation, an

Wherein the stimulation unit is configured to initiate generation of the time-varying stimulation in response to the event signal.

31. The apparatus of claim 30, wherein the apparatus is configured to configure the initial form at least partially in response to a parameter of the event signal.

32. The apparatus of claim 30, wherein the physiological event comprises a segment of sleep apnea, and wherein the sensor is to detect the segment of sleep apnea.

33. The apparatus of any one of claims 1 to 25,

wherein the memory has stored thereon a plurality of training protocols having respective indications of respective initial and expected forms,

wherein the stimulation unit comprises a user interface for enabling the subject to select one of the training protocols, an

Wherein the stimulation unit is adapted to generate the time-varying stimulation in response to the selection.

34. The apparatus of claim 33, wherein the user interface comprises a telephone.

35. The apparatus of claim 33, wherein the user interface comprises a user interface of an audio playback device.

36. The apparatus of claim 33, wherein the user interface comprises a user interface of a general purpose computer.

37. The apparatus of any one of claims 1 to 25, wherein the stimulation unit is configured to generate the time-varying stimulation when the subject is unconscious.

38. The apparatus of claim 37, wherein the stimulation unit is to generate the time-varying stimulation when the subject is coma.

39. The apparatus of claim 37, wherein the stimulation unit is to generate the time-varying stimulation when the subject is anesthetized.

40. The apparatus of any one of claims 1 to 25, wherein the multi-phase biorhythmic activity includes respiration by the subject, and wherein the stimulation unit is to configure the time-varying stimulation to direct the subject to adjust the respiration.

41. The apparatus of claim 40, wherein the subject's multi-stage biorhythmic activity is characterized by a respiration rate, and wherein the memory has stored thereon an indication of the initial form and the expected form, wherein the respiration rate in the expected form is different from the respiration rate in the initial form.

42. The device of claim 40, wherein two or more phases in the intended form include at least one respiratory phase not normally included in the multi-phase biorhythmic activity prior to generating the time-varying stimulus, and wherein the memory has stored thereon an indication of the at least one respiratory phase.

43. The apparatus of claim 40, wherein the two or more phases in the intended form include at least one respiratory phase selected from the list consisting of breath hold and post-expiration pause, and wherein the memory has stored thereon an indication of the selected respiratory phase.

44. The apparatus of claim 40, comprising an impedance load for acting on said subject and preventing airflow to said subject during a selected breathing phase from inspiration and expiration.

45. A device as claimed in claim 40, comprising a mechanical ventilator for acting on the subject and operating in conjunction with the stimulation unit.

46. The apparatus according to claim 40, wherein two or more phases of the initial form and the intended form comprise inhalation and exhalation, and wherein the memory has stored thereon the initial form and the indication, wherein the ratio I: E ratio of inhalation duration to exhalation duration in the intended form is less than the I: E ratio in the initial form.

47. The apparatus of claim 46 wherein said memory has stored thereon said initial form and said indication, wherein the I: E ratio in said expected form is between 1: 0.5 and 1: 4.

48. The apparatus of any one of claims 1 to 25, comprising a user interface for receiving input from said subject, wherein said apparatus is adapted to store an indication of said initial form and said expected form in said memory in response to said input.

49. The apparatus of claim 48, wherein the user interface is to receive an indication of a duration of two or more phases in the indication of expected form.

50. The apparatus of claim 48, wherein the user interface is configured to receive an indication of a time trend of respective durations of two or more phases in the initial form.

51. The apparatus of claim 48, wherein the user interface is to receive an indication of a duration of two or more stages in the initial form.

52. The apparatus of claim 48, wherein the user interface is to receive an indication of a duration of two or more stages in the expected form.

53. The apparatus of claim 48, wherein the user interface is configured to measure a time interval between a start indication and an end indication of at least one phase in the initial form of the indication.

54. The apparatus of claim 53, wherein the initiation and termination indications comprise respective audible indications of respiration of the subject, and wherein the user interface is to detect the visual initiation and termination indications.

55. The apparatus of claim 53, wherein the user interface is configured to receive the start and end indications from the subject at respective times and to measure the time interval in response to the receipt.