System and method for determining whether a subject is likely to be disturbed by therapy levels of stimulation during sleep sessions

Patent metadata

Field	Value
Publication number	US-11266807-B2
Application number	US-201716472621-A
Country	US
Kind code	B2
Filing date	Dec 27, 2017
Priority date	Dec 28, 2016
Publication date	Mar 8, 2022
Grant date	Mar 8, 2022

Abstract

The present disclosure pertains to a system and method for determining whether a subject is likely to be disturbed by therapy levels of stimulation provided to the subject during sleep sessions. The present system is configured to automatically identify sensitive users using electroencephalogram (EEG) information from a reference sleep session with or without stimulation. For reference sleep sessions without stimulation, the alpha activity in detected deep sleep is used to predict whether the subject is likely to be disturbed by therapy levels of stimulation. For reference sleep sessions with stimulation, the acute increase in EEG delta (e.g., 0.5-4 Hz) power and/or an arousability index are used to predict whether the subject is likely to be disturbed by therapy levels of stimulation.

First claim

What is claimed is:

1. A system configured to determine whether a subject is likely to be disturbed by therapy levels of stimulation provided to the subject during sleep sessions, the system comprising:
one or more stimulators configured to provide stimulation to the subject during sleep sessions;
one or more sensors configured to generate output signals conveying information related to brain activity in the subject during the sleep sessions; and
one or more hardware processors operatively communicating with the one or more stimulators and the one or more sensors, the one or more hardware processors configured by machine-readable instructions to:
(1) control the one or more stimulators to provide low intensity stimulation to the subject during a reference sleep session, the low intensity stimulation comprising stimulation that does not cause sleep disturbances in the subject during the reference sleep session; or
(2) control the one or more stimulators to provide high intensity stimulation to the subject during the reference sleep session, the high intensity stimulation comprising stimulation that causes sleep disturbances in the subject during the reference sleep session;
and
determine a first brain activity parameter of the subject responsive to the low intensity stimulation being provided based on the output signals during the reference sleep session, determine a second brain activity parameter of the subject responsive to the high intensity stimulation being provided based on the output signals during the reference sleep session, wherein the first brain activity parameter is different than the second brain activity parameter, responsive to determining the first brain activity parameter, compare the first brain activity parameter to a corresponding first brain activity parameter threshold that indicates whether the subject is likely to be disturbed by the therapy levels of stimulation, responsive to determining the second brain activity parameter, compare the second brain activity parameter to a corresponding second brain activity parameter threshold that indicates whether the subject is likely to be disturbed by the therapy levels of stimulation, and responsive to the first brain activity parameter breaching the first brain activity parameter threshold or the second brain activity parameter breaching the second brain activity parameter threshold, determine that the subject is likely to be disturbed by the therapy levels of stimulation.

2. The system of claim 1 , wherein the one or more stimulators comprise a tone generator, and the one or more sensors comprise one or more electroencephalogram (EEG) electrodes configured to generate one or more EEG output signals.

3. The system of claim 2 , wherein the one or more hardware processors are further configured to control the one or more stimulators to not provide stimulation to the subject during the reference sleep session;
such that:
(a) responsive to controlling the one or more stimulators to provide the low intensity stimulation, the first brain activity parameter comprises a change in an EEG delta power level caused by the low intensity stimulation, and the first brain activity parameter threshold is a threshold level for the change in the delta power that indicates whether the subject is likely to be disturbed by the therapy levels of stimulation;
(b) responsive to controlling the one or more stimulators to provide the high intensity stimulation, the second brain activity parameter comprises a quantity of automatically detected micro arousals in the subject, and the second brain activity parameter threshold is a threshold quantity of micro arousals that indicates whether the subject is likely to be disturbed by the therapy levels of stimulation; or
(c) responsive to controlling the one or more stimulators not to provide stimulation, a third brain activity parameter is determined that comprises an EEG alpha power level; and compared to a third brain activity parameter threshold comprising a threshold level for the alpha power during NREM sleep that indicates whether the subject is likely to be disturbed by the therapy levels of stimulation.

4. The system of claim 3 , wherein the one or more hardware processors are configured to control the one or more stimulators to provide the low intensity stimulation and the high intensity stimulation at different times during the same reference sleep session.

5. The system of claim 3 , wherein the one or more hardware processors are configured such that the quantity of micro arousals comprises a ratio of a quantity of micro arousals caused by the high intensity stimulation to a quantity of spontaneous micro arousals, and the threshold is a threshold ratio for the micro arousals caused by the high intensity stimulation and the spontaneous arousals.

6. The system of claim 1 , wherein the one or more stimulators and the one or more hardware processors are configured such that the low intensity stimulation comprises tones with a 30-40 decibel volume in up to five tone blocks with a randomized inter tone interval in a 5-30 second range.

7. A method for determining, with a determination system, whether a subject is likely to be disturbed by therapy levels of stimulation provided to the subject during sleep sessions, the system comprising one or more stimulators, one or more sensors, and one or more hardware processors, the method comprising:
providing, with the one or more stimulators, the stimulation to the subject during the sleep sessions;
generating, with the one or more sensors, output signals conveying information related to brain activity in the subject during the sleep sessions;
(1) controlling, with the one or more processors, the one or more stimulators to provide low intensity stimulation to the subject during a reference sleep session, the low intensity stimulation comprising stimulation that does not cause sleep disturbances in the subject during the reference sleep session; or
(2) controlling, with the one or more processors, the one or more stimulators to provide high intensity stimulation to the subject during the reference sleep session, the high intensity stimulation comprising stimulation that causes sleep disturbances in the subject during the reference sleep session;

and
determining, with the one or more processors, a first brain activity parameter of the subject responsive to the low intensity stimulation being provided based on the output signals during the reference sleep session, determine a second brain activity parameter of the subject responsive to the high intensity stimulation being provided based on the output signals during the reference sleep session, wherein the first brain activity parameter is different than the second brain activity parameter, responsive to determining the first brain activity parameter, comparing the first brain activity parameter to a corresponding first brain activity parameter threshold that indicates whether the subject is likely to be disturbed by the therapy levels of stimulation, responsive to determining the second brain activity parameter, comparing the second brain activity parameter to a corresponding second brain activity parameter threshold that indicates whether the subject is likely to be disturbed by the therapy levels of stimulation, and responsive to the first brain activity parameter breaching the first brain activity parameter threshold or the second brain activity parameter breaching the second brain activity parameter threshold, determining that the subject is likely to be disturbed by the therapy levels of stimulation.

8. The method of claim 7 , wherein the one or more stimulators comprise a tone generator, and the one or more sensors comprise one or more electroencephalogram (EEG) electrode

Assignees

• Koninklijke Philips Nv

Inventors

• Garcia Molina Gary Nelson
• Vissapragada Venkata Satya Surya Subrahmanya Sreeram
• Pfundtner Stefan
• Tsoneva Tsvetomira Kirova
• Mahadevan Anandi

Classifications

• A61M2021/0044

  by the sight sense · CPC title

• A61B5/7282 Primary

  Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818) · CPC title

• A61M2230/10

  Electroencephalographic signals · CPC title

• A61M21/02 Primary

  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) · CPC title

• A61B5/4812

  Detecting sleep stages or cycles · CPC title