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

NCT ID: NCT04121923

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-05-30

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Participant

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.

Group Type: EXPERIMENTAL

Belun Ring Pulse Oximeter

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinimark, LLC

OTHER

Sponsor Role: collaborator

Belun Technology Company Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mountain Sleep Diagnostics

Denver, Colorado, United States

Countries

United States

References

Gu W, Leung L, Kwok KC, Wu IC, Folz RJ, Chiang AA. Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. J Clin Sleep Med. 2020 Sep 15;16(9):1611-1617. doi: 10.5664/jcsm.8592.

Reference Type: DERIVED

PMID: 32464087 (View on PubMed)

Other Identifiers

PR 2018-259

Identifier Type: -

Identifier Source: org_study_id