Sleep Apnea, Obstructive
Conditions
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.
Interventions
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
Belun Technology Company Limited
Clinimark, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Ability of the Ring-REI Measured by Belun Ring to Gauge the AHI Measured by PSG | 1 overnight sleep study (1 Day) | Apnea-Hypopnea Index (AHI) is defined as the total number of apnea and hypopnea events per hour of sleep, where higher values indicate more severe sleep-disordered breathing. In this study, standard overnight polysomnography(PSG) and Belun Ring pulse oximeter were simultaneously measured. The AHI derived from PSG data was served as the reference. The primary outcome evaluates the accuracy of the Belun Ring by calculating the difference in Ring-REI by the Belun Ring compared with AHI derived from PSG recordings for each participant. The difference was calculated as: Ring-REI (Belun Ring) - AHI (PSG). Negative values indicate that the Belun Ring estimated a lower AHI than PSG, while positive values indicate that the Belun Ring estimated a higher AHI than PSG. Summary statistics of these differences were used to assess agreement between the Belun Ring device and PSG in measuring sleep apnea severity. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 16.3 |
| Apnea-Hypopnea Index (AHI) | 18.5 events per hour STANDARD_DEVIATION 15.4 |
| Body Mass Index (BMI) | 30.5 kg per square meter STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
None listed