Positional obstructive sleep apnea detection system

Inventors

Goff, Thomas G.CHIANG, KirbyBowditch, Nathaniel L.

Assignees

Oura Health Oy

Publication Number

US-11660228-B2

Publication Date

2023-05-30

Expiration Date

2037-05-19

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Abstract

An obstructive sleep apnea detection device including an optical engagement surface adapted to engage a user's skin; a light source adapted to emit light from the optical engagement surface; a photodetector adapted to detect light at the optical engagement surface and to generate a detected light signal; a position sensor adapted to determine patient sleeping position; a controller adapted to determine and record in memory blood oxygen saturation values computed from the detected light signal and user position information from the position sensor; and a housing supporting the optical engagement surface, the photodetector, the light source, the position sensor, and the controller.

Core Innovation

The invention provides a positional obstructive sleep apnea detection system combining a pulse oximeter with a position sensor to obtain information about a subject's sleep position and blood oxygen saturation. The device is worn on the skin, typically the forehead, and is adapted to emit light, detect reflected light, compute blood oxygen saturation values, and determine sleeping position. The system analyzes the frequency, duration, and severity of blood oxygen desaturation events correlated with different sleep positions to diagnose obstructive sleep apnea (OSA) and differentiate it from other sleep disorders like central sleep apnea (CSA).

The problem being solved is the difficulty and inconvenience in diagnosing obstructive sleep apnea due to existing diagnostic methods like in-lab polysomnography being costly, intrusive, and capturing only a single night of data. Moreover, there is a lack of convenient means to correlate sleep position with apnea severity or to assess treatment efficacy, particularly with continuous positive airway pressure (PAP) therapy. Current diagnostic approaches often fail to account for the significant effect of sleeping position on apnea events, contributing to a large undiagnosed population and inadequate tracking of therapy outcomes.

Claims Coverage

The claims present two independent devices for obstructive sleep apnea detection focusing on optical and positional sensing components integrated into a housing, and a method for generating and analyzing blood oxygen saturation events correlated to patient sleeping positions.

Integrated optical engagement surface with downward extension

The device includes a housing with a peripheral portion and a sensor interface element extending downward from it, forming an optical engagement surface adapted to engage the user's skin, ensuring effective optical coupling.

Dual optical elements with position-correlated detection

It uses a first optical element emitting light through a first opening and a second optical element receiving light through a second opening to generate detected light signals corresponding to different sleeping positions, comprising distinct blood oxygen saturation event sets.

Position sensor determining patient sleeping position

The device incorporates a position sensor, such as an accelerometer, configured to determine multiple patient sleeping positions corresponding to the detected light signals.

Controller analyzing and recording sleep-position correlated oxygen saturation data

A controller obtains analysis results by comparing the frequency and average values of blood oxygen saturation events between positions, recording the results in memory to differentiate sleep apnea severity relative to position.

Flexible material with adhesive extending beneath housing

The device includes a flexible material disposed below the housing's peripheral portion, potentially adhesive, with the optical coupling elements extending below this material to ensure contact and stability on the skin.

Tapered optical coupling elements extending below flexible material

Optical coupling elements extend a specified distance (0.1 mm to 2.5 mm) below the flexible material to optimize skin contact and signal quality.

Communicator adapted for result transmission

An optional communicator, such as a wireless transmitter, is included for transmitting the analyzed sleep position and blood oxygen data externally.

Optical surface and opening dimension design

The optical engagement surface preferably shaped for forehead placement, with specific dimensions where diameters of optical openings are smaller than active areas of respective optical elements, optimizing signal transmission and detection.

Position determination from detected light signals

The position sensor and controller can derive patient sleeping position from variations in the detected light signals themselves, not solely relying on accelerometer data.

The independent claims collectively describe a device integrating optical and positional sensing elements with specialized housing and flexible interface materials to detect and analyze blood oxygen saturation events in relation to sleep positions. The controller produces analysis results based on frequency and severity comparisons of events between positions, recording and optionally communicating this data, enabling advanced positional obstructive sleep apnea detection.

Stated Advantages

Provides convenient, non-intrusive overnight monitoring in a user's typical sleep environment, capturing multiple nights of sleep data for increased diagnostic accuracy.

Enables differentiation between obstructive sleep apnea and central sleep apnea by correlating blood oxygen desaturation events with sleeping position and respiratory effort data.

Facilitates patient understanding of the positional impact on their sleep apnea, potentially improving therapy adherence and personalized treatment assessments.

Offers the ability to assess efficacy of various therapies, including PAP and alternative treatments, through objective monitoring.

The compact, wearable device design with flexible skin-contacting materials enhances comfort and signal quality during sleep.

Documented Applications

Home-based sleep apnea risk assessment and diagnosis through combined pulse oximetry and position sensing.

Monitoring and differentiating types of sleep-disordered breathing, specifically positional obstructive sleep apnea and central sleep apnea.

Assessment and feedback on PAP therapy effectiveness and alternative treatment modalities for sleep apnea.

Detection of related sleep conditions such as restless leg syndrome and nocturia by analyzing motion and position data.

Longitudinal sleep quality tracking to understand variability caused by health and environmental factors.

Potential use in identifying other oxygen-related illnesses like COPD, pulmonary edema, and congestive heart failure.

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