Back to resultsValidation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Belun Ring Pulse Oximeter
Sponsored by
About this trial
This is an interventional screening trial for Sleep Apnea, Obstructive
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.
Sites / Locations
- Mountain Sleep Diagnostics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participant
Arm Description
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.
Outcomes
Primary Outcome Measures
Apnea-Hypopnea Index (AHI)
To evaluate the ability of the Belun ring pulse oximeter to correctly gauge the Apnea-Hypopnea Index (AHI).
Secondary Outcome Measures
Full Information
NCT ID
NCT04121923
First Posted
October 9, 2019
Last Updated
October 9, 2019
Sponsor
Belun Technology Company Limited
Collaborators
Clinimark, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04121923
Brief Title
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Official Title
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belun Technology Company Limited
Collaborators
Clinimark, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Belun Ring Pulse Oximeter
Intervention Description
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
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI)
Description
To evaluate the ability of the Belun ring pulse oximeter to correctly gauge the Apnea-Hypopnea Index (AHI).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Mountain Sleep Diagnostics
City
Denver
State/Province
Colorado
ZIP/Postal Code
80231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32464087
Citation
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.
Results Reference
derived
Learn more about this trial
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
We'll reach out to this number within 24 hrs