Sleep Architecture, Sleep-Disordered Breathing
Conditions
Keywords
Obstructive Sleep Apnea, Wearable, Home Sleep Apnea Testing, Photoplethysmography, Validation, Artificial Intelligence
Brief summary
OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.
Interventions
DEVICEBelun Ring
The Belun Ring sensor will be applied to the proximal phalanx of the index finger in the non-dominant hand of the participating individuals prior to their sleep onset in the sleep lab and will be removed upon awakening at the end of the sleep period on the following morning. The attended in-lab sleep study will be performed simultaneously in a standard fashion.
DIAGNOSTIC_TESTPSG
All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs 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 vis-à-vis with the results of the PSG on the same patient.
Sponsors
Belun Technology Company Limited
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form. * Age 18-80 * Clinically assessed and suspicious for OSA
Exclusion criteria
* Full night PAP titration study * On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator * Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF \< 55%, left ventricular assist device (LVAD), or status post cardiac transplantation * Patients taking narcotics * Recent hospitalization or recent surgery in the past 30 days * Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Stage Parameters | 1 overnight sleep study (1 Day) | To determine the accuracy of BLS-100 sleep stage parameters to classify the human sleep stage (Wake, REM and Non-REM) by comparing to the classification results of in-lab PSG. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmbrose A Chiang, MD
University Hospitals Cleveland Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 14.4 |
| Apnea-Hypopnea Index (AHI) | 15.8 events per hour |
| Body Mass Index (BMI) | 38.7 kg per square meter STANDARD_DEVIATION 9.3 |
| Race/Ethnicity, Customized Race African American | 52 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Caucasian | 24 Participants |
| Race/Ethnicity, Customized Race Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race Others | 1 Participants |
| Race/Ethnicity, Customized Race Unknown | 4 Participants |
| Region of Enrollment United States | 84 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 136 |
| other Total, other adverse events | 0 / 136 |
| serious Total, serious adverse events | 0 / 136 |
Outcome results
None listed