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

NCT04121923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-10-10

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

Belun Ring Pulse Oximeter

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

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Belun Technology Company Limited

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-04-15
Completion
2019-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121923 on ClinicalTrials.gov