# US 12,214,141 B2 · Method to shift circadian rhythm responsive to future therapy

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- Number: US 12,214,141 B2
- Document ID: US12214141B2
- Status: Granted
- Kind: B2
- Application number: 17/248,911
- Filed: 2021-02-12
- Published: 2021-06-03
- Granted: 2025-02-04
- Earliest claimed: 2018-06-05
- Assignees: Timeshifter, Inc.
- Applicants: Timeshifter, Inc.
- Inventors: Steven Lockley; Tony Hanna; Jacob Ravn; Mickey Beyer-Clausen; Fredric Maxik
- Web page: https://patentgrep.com/patent/US12214141B2

## CPC

- A61M 21/00: Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
- A61M 21/02: for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia (for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021)
- A61B 5/4812: {Detecting sleep stages or cycles}
- A61N 5/0618: {Psychological treatment}
- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 20/60: relating to nutrition control, e.g. diets
- G16H 20/70: relating to mental therapies, e.g. psychological therapy or autogenous training
- G16H 40/67: for remote operation
- H05B 47/16: by timing means
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61M 2021/0044: {by the sight sense}
- A61M 2021/0077: {with application of chemical or pharmacological stimulus}
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/587: Lighting arrangements
- A61N 2005/0626: {Monitoring, verifying, controlling systems and methods}
- Y02B 20/40: Control techniques providing energy savings, e.g. smart controller or presence detection
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H05B: ELECTRIC HEATING; ELECTRIC LIGHT SOURCES NOT OTHERWISE PROVIDED FOR; CIRCUIT ARRANGEMENTS FOR ELECTRIC LIGHT SOURCES, IN GENERAL
- Y02B: CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO BUILDINGS, e.g. HOUSING, HOUSE APPLIANCES OR RELATED END-USER APPLICATIONS

## Abstract

A circadian rhythm shifting method to improve future therapy effectiveness including receiving a future therapy indication, identifying a circadian cycle period that performance of the therapy is preferred, receiving a user normal circadian rhythm indication, defining a user circadian performance time range, identifying a circadian shift to change the user circadian performance time range, defining a user circadian shift protocol to cause the identified circadian shift, and providing an indication to perform an activity of the user circadian shift protocol.

## Claims

### Claim 1

A method of determining and facilitating shifting of a circadian rhythm of a user to improve the effectiveness of a future therapy by a server comprising a processor, the method comprising:
receiving at the server a future therapy indication comprising:
a therapy to be administered;
a therapy date defining the day the therapy will be administered; and
a therapy time defining a time of day the therapy will be administered;
identifying by the processor one or more periods during a circadian cycle during which performance of the therapy is preferred, defining a circadian performance time range;
receiving at the server an indication of a normal circadian rhythm of the user;
determining by the processor the position of the circadian performance time range within the normal circadian rhythm of the user, defining a user circadian performance time range;
identifying by the processor a circadian shift necessary to change the user circadian performance time range such that the therapy time occurs within the user circadian performance time range, the circadian shift comprising a circadian shift direction and a circadian shift magnitude;
receiving at the server an indication of a present circadian phase of the user;
defining by the processor a user circadian shift protocol responsive to the circadian shift direction, circadian shift magnitude, and a number of days between a present day and the therapy date, the user circadian shift protocol comprising one or more activities scheduled to be performed at a certain date and time and comprising:
receiving at the server an indication of a second activity to be performed and comprised by the one or more activities;
determining by the processor a first time of day to perform a first activity of the one or more activities corresponding to the user circadian performance time range responsive to the present circadian phase of the user and the second activity, defining a first activity clock performance time;
identifying by the processor one or more periods during a circadian cycle during which performance of the second activity is preferred responsive to the first activity, defining a second activity circadian performance time;
determining by the processor the position of the second circadian performance time within the normal circadian rhythm of the user, defining a second activity user circadian performance time; and
determining by the processor a second time of day corresponding to the second activity user circadian performance time, defining a second activity clock performance time;
providing by the processor a first indication to perform the first activity of the one or more activities comprised by the user circadian shift protocol at the first activity clock performance time comprising at least one of illuminating a first indicator light, operating a sound-generating device to provide a first audio indication, operating a visual display to display a first message, and transmitting a first message to be received on a computerized device; and;
providing by the processor a second indication to the user to perform the second activity at the second activity clock performance comprising at least one of illuminating a second indicator light that is differentiated from the first indicator light, operating a sound-generating device to provide a second audio indication that is differentiated from the first audio indication, operating a visual display to display a second message that is differentiated from the first message, and transmitting a second message that is differentiated from the first message to be received on the computerized device.

### Claim 2 (depends on 1)

The method of claim 1 wherein the one or more activities comprises at least one of a light exposure or light avoidance activity, a chronobiotic activity, a nutritional consumption activity, a physical activity, and a rest activity.

### Claim 3 (depends on 1)

The method of claim 1 wherein providing an indication to perform the activity comprises at least one of illuminating an indicator light, operating a sound-generating device to provide an audio indication, operating a visual display to display a message, and transmitting a message to be received on a computerized device.

### Claim 4 (depends on 1)

The method of claim 1 wherein the normal circadian rhythm of the user is at least one of a central circadian clock of the user and a peripheral circadian clock of the user.

### Claim 5 (depends on 1)

The method of claim 1 wherein the present circadian phase is a first present circadian phase, the method further comprising:
receiving at the server an indication of when the activity was performed, defining a performance time;
determining by the processor an estimated circadian phase coinciding with the performance time;
determining by the processor an estimated efficacy of the activity responsive to the estimated circadian phase, where the estimated efficacy is less than an ideal efficacy;
determining by the processor a second user circadian performance time to perform a second performance of the activity responsive to at least one of the estimated efficacy, the circadian performance time, the user circadian performance time, and a second indication of the present circadian phase of the user;
determining by the processor a second clock performance time responsive to the second user circadian performance time; and
providing by the server an indication to the user to perform the second performance of the activity at the second clock performance time.

### Claim 6 (depends on 1)

The method of claim 1 wherein the indication of the present circadian phase of the user and the normal circadian rhythm of the user is at least one of a sleep-wake cycle of the user, light-dark exposure, chronotype, sex, age, present time zone, future time zone, present work shift, future work shift, heat rate, heart rate variability, core temperature, skin temperature, and a biological marker.

### Claim 7 (depends on 1)

The method of claim 1 further comprising:
receiving at the server an indication of when the activity was performed, defining a performance time;
determining by the processor an estimated circadian phase coinciding with the performance time;
determining by the processor an estimated efficacy of the activity responsive to the estimated circadian phase, where the estimated efficacy is less than an ideal efficacy;
determining by the processor a second user circadian activity time to perform a second activity of the user circadian shift protocol responsive to at least one of the estimated efficacy, the circadian performance time, and the user circadian performance time;
determining by the processor a second clock performance time responsive to the second user circadian activity time; and
providing by the processor an indication to the user to perform the second activity at the second clock performance time.

### Claim 8 (depends on 1)

The method of claim 1 further comprising receiving at the server an indication of a present circadian phase of the user; wherein each of the first activity clock performance time and the second activity clock performance time is determined responsive to the present circadian phase of the user.

### Claim 9 (depends on 1)

The method of claim 1 further comprising receiving at the server a sleep pattern for the user, wherein the user circadian shift protocol is defined responsive to the sleep pattern.

### Claim 10 (depends on 1)

The method of claim 1 further comprising receiving at the server an activity preference indication for the user identifying an activity the user will not perform, defining an excluded activity; wherein defining the user circadian shift protocol comprises defining one or more activities excluding the excluded activity.

### Claim 11 (depends on 1)

The method of claim 1 further comprising:
receiving at the server an indication of non-performance of an activity, defining a non-performed activity; and
adjusting the user circadian shift protocol responsive to the non-performed activity.

### Claim 12

A method of determining and facilitating shifting of a circadian rhythm of a user to improve the effectiveness of a future therapy by a server comprising a processor, the method comprising:
receiving at the server a future therapy indication comprising:
a therapy to be administered;
a therapy date defining the day the therapy will be administered; and
a therapy time defining a time of day the therapy will be administered;
identifying by the processor one or more periods during a circadian cycle during which performance of the therapy is preferred, defining a circadian performance time range;
receiving at the server an indication of a normal circadian rhythm of the user;
receiving at the server an indication of a present circadian phase of the user;
determining by the processor the position of the circadian performance time range within the normal circadian rhythm of the user, defining a user circadian performance time range;
identifying by the processor a circadian shift necessary to change the user circadian performance time range such that the therapy time occurs within the user circadian performance time range, the circadian shift comprising a circadian shift direction and a circadian shift magnitude;
defining by the processor a user circadian shift protocol responsive to the circadian shift direction, circadian shift magnitude, and a number of days between a present day and the therapy date, the user circadian shift protocol comprising one or more activities scheduled to be performed at a date and time of day corresponding to the user circadian performance time, defining a clock performance time, comprising:
receiving at the server an indication of a second activity to be performed and comprised by the one or more activities;
determining by the processor a first time of day to perform a first activity of the one or more activities corresponding to the user circadian performance time range responsive to the present circadian phase of the user and the second activity, defining a first activity clock performance time;
identifying by the processor one or more periods during a circadian cycle during which performance of the second activity is preferred responsive to the first activity, defining a second activity circadian performance time;
determining by the processor the position of the second circadian performance time within the normal circadian rhythm of the user, defining a second activity user circadian performance time; and
determining by the processor a second time of day corresponding to the second activity user circadian performance time, defining a second activity clock performance time;
providing by the server an indication to perform an activity of the one or more activities at the clock performance time at the first activity clock performance time comprising at least one of illuminating a first indicator light, operating a sound-generating device to provide a first audio indication, operating a visual display to display a first message, and transmitting a first message to be received on a computerized device; and
providing by the processor a second indication to the user to perform the second activity at the second activity clock performance comprising at least one of illuminating a second indicator light that is differentiated from the first indicator light, operating a sound-generating device to provide a second audio indication that is differentiated from the first audio indication, operating a visual display to display a second message that is differentiated from the first message, and transmitting a second message that is differentiated from the first message to be received on the computerized device;
wherein the one or more activities comprises at least one of a light exposure or light avoidance activity, a chronobiotic activity, a nutritional consumption activity, a physical activity, and a rest activity.

### Claim 13 (depends on 12)

The method of claim 12 wherein the present circadian phase is a first present circadian phase, the method further comprising:
receiving at the server an indication of when the activity was performed, defining a performance time;
determining by the processor an estimated circadian phase coinciding with the performance time;
determining by the processor an estimated efficacy of the activity responsive to the estimated circadian phase, where the estimated efficacy is less than an ideal efficacy;
determining by the processor a second user circadian performance time to perform a second performance of the activity responsive to at least one of the estimated efficacy, the circadian performance time, the user circadian performance time, and a second indication of the present circadian phase of the user;
determining by the processor a second clock performance time responsive to the second user circadian performance time; and
providing by the server an indication to the user to perform the second performance of the activity at the second clock performance time.

### Claim 14 (depends on 12)

The method of claim 12 wherein the indication of the present circadian phase of the user and the normal circadian rhythm of the user is at least one of a sleep-wake cycle of the user, light-dark exposure, chronotype, sex, age, present time zone, future time zone, present work shift, future work shift, heat rate, heart rate variability, core temperature, skin temperature, and a biological marker.

### Claim 15 (depends on 12)

The method of claim 12 further comprising:
receiving at the server an indication of when the activity was performed, defining a performance time;
determining by the processor an estimated circadian phase coinciding with the performance time;
determining by the processor an estimated efficacy of the activity responsive to the estimated circadian phase, where the estimated efficacy is less than an ideal efficacy;
determining by the processor a second user circadian activity time to perform a second activity of the therapy responsive to at least one of the estimated efficacy, the circadian performance time, and the user circadian performance time;
determining by the processor a second clock performance time responsive to the second user circadian activity time responsive to the second user circadian activity time; and
at least one of providing by the server an indication to the user to perform the second performance of the activity at the second clock performance time and administering the second performance of the therapy to the user at the second clock performance time.

### Claim 16 (depends on 12)

The method of claim 12 further comprising receiving at the server an indication of a present circadian phase of the user; wherein each of the first clock performance time and the second clock performance time is determined responsive to the present circadian phase of the user.

### Claim 17

A system for determining and facilitating shifting of a circadian rhythm of a user to improve the effectiveness of a future therapy comprising:
a communication device configured to:
receive a future therapy indication comprising:
a therapy to be administered;
a therapy date defining the day the therapy will be administered; and
a therapy time defining a time of day the therapy will be administered;
receive an indication of a normal circadian rhythm of the user;
receive an indication of a present circadian phase of the user;
receive an indication of a second activity to be performed; and
transmit a message to be received on a computerized device;
a processor positioned in communication with the communication device and configured to:
identify one or more periods during a circadian cycle during which performance of the therapy is preferred, defining a circadian performance time range;
determine the position of the circadian performance time range within the normal circadian rhythm of the user, defining a user circadian performance time range;
define a user circadian shift protocol responsive to the circadian shift direction, circadian shift magnitude, and a number of days between a present day and the therapy date, the user circadian shift protocol comprising one or more activities scheduled to be performed at a certain date and time, comprising:
determining a first time of day to perform a first activity of the one or more activities corresponding to the user circadian performance time range responsive to the present circadian phase of the user and the second activity, defining a first activity clock performance time;
identifying one or more periods during a circadian cycle during which performance of the second activity is preferred responsive to the first activity, defining a second activity circadian performance time;
determining by the processor the position of the second circadian performance time within the normal circadian rhythm of the user, defining a second activity user circadian performance time; and
determining by the processor a second time of day corresponding to the second activity user circadian performance time, defining a second activity clock performance time;
at least one of illuminate an indicator light, operate a sound-generating device to provide an audio indication, and operate a visual display to display a message at the first clock performance time; and
at least one of illuminate an indicator light, operate a sound-generating device to provide an audio indication, and operate a visual display to display a message at the second clock performance time.

### Claim 18 (depends on 17)

The system of claim 17 wherein:
the present circadian phase is a first present circadian phase;
the communication device is further configured to receive an indication of when the activity was performed, defining a performance time;
the processor is further configured to:
determine an estimated circadian phase coinciding with the performance time;
determine an estimated efficacy of the activity responsive to the estimated circadian phase, where the estimated efficacy is less than an ideal efficacy;
determine a second user circadian performance time to perform a second performance of the activity responsive to at least one of the estimated efficacy, the circadian performance time, the user circadian performance time, and a second indication of the present circadian phase of the user;
determine a second clock performance time responsive to the second user circadian performance time; and
at least one of illuminate an indicator light, operate a sound-generating device to provide an audio indication, and operate a visual display to display a message at the second clock performance time; and
wherein the communication device is further configured to transmit the message to be received on a user computerized device at the second clock performance time.

### Claim 19 (depends on 17)

The system of claim 17 wherein the communication device is configured to transmit the message to be received on a user computerized device by at least one of transmitting the message directly to the computerized device and transmitting the message to the computerized device across a network according to a network protocol.
