Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the sensitivity and specificity of the Belun Ring Pulse Oximetry system for screening of obstructive sleep apnea (OSA) in adults during standard polysomnography sleep study conditions. The primary outcome metric is the Apnea-Hypopnea Index (AHI). The goal, in its entirety, is to evaluate the performance of the Belun Ring Pulse Oximeter during a standard polysomnography sleep study and its ability to compare to the determined Apnea-Hypopnea Index (AHI) of the subjects. It is expected that the Belun Ring Pulse Oximeter will adequately record SpO2, pulse rate, body position and heart rate variability throughout the duration of the study.

Official Title
-----------------
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Device: Belun Ring Pulse Oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have the ability to understand and provide written informed consent. Subject is 18 to 90 years of age. Subject must be willing and able to comply with study procedures and duration. Male or female of any race. Exclusion Criteria: Subject requires oxygen therapy or noninvasive ventilation. Subject has a current diagnosis of chronic obstructive pulmonary disorder (COPD), neuromuscular disease, periodic limb movement, or narcolepsy. Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.) Subject is on medication known to interfere with heart rate, such as beta blockers, digoxin, or calcium receptor agonists. Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported). Unwillingness or inability to remove colored nail polish from test digits. Other known health condition, which should be considered.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant<br>All patients scheduled for attended overnight in-lab polysomnography (PSG) will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device with the results of the PSG on the same patient. There will be no separate arm to test a different device. | Device: Belun Ring Pulse Oximeter<br>* Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Total sleep time (Ring-TST) and respiratory event index (Ring-REI) are estimated<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | To evaluate the ability of the Belun ring pulse oximeter to correctly gauge the Apnea-Hypopnea Index (AHI). | 2 years |