Status:
COMPLETED
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Lead Sponsor:
Belun Technology Company Limited
Collaborating Sponsors:
Clinimark, LLC
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-90 years
Phase:
NA
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 polysomnograph...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04121923
Start Date
March 1 2018
End Date
May 30 2019
Last Update
October 10 2019
Active Locations (1)
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1
Mountain Sleep Diagnostics
Denver, Colorado, United States, 80231