Cranial nerve stimulation to treat depression during sleep

• US 9,302,109 B2
• Filed: 04/25/2014
• Issued: 04/05/2016
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Sabesan, Shivkumar
• Primary Examiner(s): Lavert, Nicole F.
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/262,508
• Publication Number:
  US 20150306392A1
• Time in Patent Office: 711 Days
• Field of Search: 607/2, 607/9, 607/45
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/398 Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

A method includes determining sleep cycle information related to a sleep cycle of a patient based on body parameter data. The method also includes adjusting a cranial nerve stimulation parameter based on the sleep cycle information. The method further includes applying a cranial nerve stimulation therapy to treat depression based on the adjusted cranial nerve stimulation parameter.

Claims

1. A method comprising:

determining, at a computing device, sleep cycle information associated with a sleep cycle of a patient based on body parameter data;

adjusting, at the computing device, a cranial nerve stimulation parameter based on the sleep cycle information, wherein the sleep cycle information includes an amount of time the patient has spent in a particular sleep stage; and

treating depression in the patient by initiating application of a cranial nerve stimulation therapy to the patient based on the adjusted cranial nerve stimulation parameter.

2. The method of claim 1, wherein the body parameter data comprises at least one of electroencephalography (EEG) data, electrooculography (EOG) data, electromyography (EMG) data, electrocardiography (ECG) data, respiration data, or accelerometer data.

3. The method of claim 1, wherein the sleep cycle information further includes one of a sleep stage transition, an amount of time the patient has spent in one or more sleep stages during a particular sleep cycle, or an amount of time the patient has spent in the one or more sleep stages during a sleep period that includes multiple sleep cycles.

4. The method of claim 1, further comprising receiving the body parameter data from a sensor monitoring the patient.

5. The method of claim 1, further comprising:

determining efficacy information of the cranial nerve stimulation therapy based on the sleep cycle information;

determining a second adjusted cranial nerve stimulation parameter based on the efficacy information; and

adjusting the cranial nerve stimulation therapy based on the second adjusted cranial nerve stimulation parameter.

6. The method of claim 5, further comprising:

generating a report that includes the efficacy information, the second adjusted cranial nerve stimulation parameter, or a combination thereof; and

communicating the report to at least one of the patient or a health care provider.

7. The method of claim 1, wherein the sleep cycle information further includes an amount of time the patient spent in a rapid eye movement (REM) stage sleep during a sleep period that includes one or more sleep cycles, and when the amount of time the patient has spent in the REM stage sleep is less than a threshold, the cranial nerve stimulation parameter is adjusted to apply the cranial nerve stimulation therapy to decrease brain synchrony.

8. The method of claim 1, wherein the cranial nerve stimulation therapy is applied to a vagus nerve, a trigeminal nerve, a hypoglossal nerve, a glossopharyngeal nerve, or a combination thereof, of the patient such that synchrony of a brain of the patient substantially conforms to a synchrony profile, and wherein the sleep cycle information further includes the particular sleep stage of the patient.

9. The method of claim 1, wherein the cranial nerve stimulation parameter includes at least one of a pulse width, an output current, a cranial nerve stimulation frequency, a cranial nerve stimulation duty cycle, a particular nerve or nerves stimulated, a cranial nerve stimulation frequency sweep, a cranial nerve stimulation on-time, or a cranial nerve stimulation off-time.

19. The method of claim 1, wherein the adjusted cranial nerve stimulation parameter includes a cranial nerve stimulation frequency less than 100 hertz (Hz) when transitioning the patient from stage 1 sleep into stage 2 sleep or from stage 2 sleep into stage 3 sleep.

20. The method of claim 1, wherein the adjusted cranial nerve stimulation parameter includes a cranial nerve stimulation frequency greater than or equal to 100 hertz (Hz) when transitioning the patient from stage 3 sleep into rapid eye movement (REM) stage sleep.

10. A device comprising:

a processor configured to;

determine sleep cycle information associated with a sleep cycle of a patient based on body parameter data; and

adjust a cranial nerve stimulation parameter based on the sleep cycle information, wherein the sleep cycle information includes an amount of time the patient has spent in a particular sleep stage;

a memory coupled to the processor; and

a therapy delivery unit configured to apply a cranial nerve stimulation therapy to treat depression in the patient based on the adjusted cranial nerve stimulation parameter.

11. The device of claim 10, wherein the processor is further configured to:

determine efficacy information of the cranial nerve stimulation therapy; and

communicate the efficacy information of the cranial nerve stimulation therapy to a health care provider, the patient, or a combination thereof.

12. The device of claim 11, wherein the efficacy information of the cranial nerve stimulation therapy is determined based on a comparison of the sleep cycle information to second sleep cycle information of the patient prior to receiving the cranial nerve stimulation therapy.

13. The device of claim 11, wherein the efficacy information of the cranial nerve stimulation therapy is determined based on a comparison of an amount of time the patient has spent in rapid eye movement (REM) stage sleep to a threshold.

14. The device of claim 10, further comprising a transceiver coupled to the processor, the transceiver configured to communicate with a sensor data gathering unit to receive the body parameter data from a sensor that is attached to the patient.

15. The device of claim 11, wherein the processor is further configured to adjust the adjusted cranial nerve stimulation parameter based on the efficacy information.

16. A non-transitory computer-readable medium comprising instructions executable by a processor to:

determine sleep cycle information associated with a sleep cycle of a patient based on body parameter data;

adjust a cranial nerve stimulation parameter based on the sleep cycle information, wherein the sleep cycle information includes an amount of time the patient has spent in a particular sleep stage; and

treat depression in the patient by initiating application of a cranial nerve stimulation therapy to the patient based on the adjusted cranial nerve stimulation parameter.

17. The non-transitory computer-readable medium of claim 16, wherein the cranial nerve stimulation therapy comprises a microburst cranial nerve stimulation therapy.

18. The non-transitory computer-readable medium of claim 17, wherein the adjusted cranial nerve stimulation parameter includes at least one a cranial nerve stimulation frequency between 100 hertz (Hz) and 250 Hz, a pulse width between 250 microseconds and 500 microseconds, pulses per burst between 2 and 10, an interburst interval of 100 milliseconds to 1 second, or a burst duration of 100 milliseconds.