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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121923
• Other study ID #: PR 2018-259
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: October 2019
• Source: Belun Technology Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 30, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Mountain Sleep Diagnostics	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Belun Technology Company Limited	Clinimark, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index (AHI)	To evaluate the ability of the Belun ring pulse oximeter to correctly gauge the Apnea-Hypopnea Index (AHI).	2 years