An interventional study of Belun Ring and PSG in Obstructive Sleep Apnea, sponsored by University Hospitals Cleveland Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Device feasibility
This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the gold standard for diagnosis of obstructive sleep apnea. Our hypothesis is that the Belun-Ring, a type 4 portable monitoring device, is overall sensitive and specific for evaluation of obstructive sleep apnea when compared to the attended overnight in-lab polysomnography.
This study will include all patients who are scheduled to do an attended overnight in-lab polysomnography in 2 sleep labs owned by University Hospitals Cleveland Medical Center. These patients will receive email recruitment forms 2 weeks prior their scheduled polysomnography. Whether they are interested or not, patients are supposed to call or email the study's central contact person. Both phone number and email address of the central contact person are noted in the email recruitment form. For those patients who did not make any contact with the study's central contact person, they will be screened for eligibility by sub-investigators through chart review. List of eligible patients will be sent to the central contact backup person who is basically in-charge of making phone calls to the patients. This person will further confirm patients' eligibility over the phone and ask if they are interested. If a patient is interested, the central contact backup person will inform the sub-investigators who, in turn, will assign a unique patient identifier to the interested subject and inform the sleep lab contact person. The sleep lab contact person will, in turn, inform the sleep technicians on-call ahead of time about the list of interested subjects. On the night of the polysomnography testing of the interested subject, the latter will receive questionnaires and written informed consent form related to the study which will be explained by the sleep technician. After the subject had completed and signed the questionnaires and written informed consent form respectively, the sleep technician will apply the Belun Ring device on the patient as well as the electrodes and sensors included in a routine polysomnography. The following day, data from Belun Ring device will be uploaded to the laptop while another sleep technician will read the polysomnography. Sub-investigators will enter the data from the questionnaires, Belun Ring device, and polysomnography in the secured University Hospitals Redcap (UHRedcap). Once the target number of subjects are reached, all data will be sent to statistician for analysis.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 113 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients scheduled for attended overnight in-lab polysomnography (PSG), also known as sleep study, 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. There will be no separate arm to test a different device.
Device: Belun Ring · Diagnostic Test: PSG
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.
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.
Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy)
Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea
Time frame: Same night when both testing were done on the same subject
Sensitivity
Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea
Time frame: Same night when both testing were done on the same subject
Specificity
Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea
Time frame: Same night when both testing were done on the same subject
| Milestone | Participant |
|---|---|
| Started | 113 |
| Completed | 78 |
| Not completed | 35 |
| Withdrew: Protocol violation | 35 |
Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea
| proportion of events | Belun Ring Study Participants |
|---|---|
| AHI cut off of 5 | 0.564 (0.447 to 0.676) |
| AHI cut off of 15 | 0.808 (0.703 to 0.888) |
| AHI cut off of 30 | 0.910 (0.824 to 0.963) |
Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea
| proportion of events | Belun Ring Study Participants |
|---|---|
| AHI cut off at 5 | 1.000 (0.918 to 1.000) |
| AHI cut off at 15 | 0.931 (0.772 to 0.992) |
| AHI cut off at 30 | 0.714 (0.419 to 0.916) |
Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea
| proportion of events | Belun Ring Study Participants |
|---|---|
| AHI cut off of 5 | 0.029 (0.001 to 0.149) |
| AHI cut off of 15 | 0.735 (0.589 to 0.850) |
| AHI cut off of 30 | 0.953 (0.869 to 0.990) |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Belun Ring Device | 0/78 (0%) | 0/78 (0%) | 0/78 (0%) |
subjects that are eligible and willing to be consented to participate in the study and whose length of data recording is sufficient for Belun Ring Analysis
| Age, Continuous(years) | Participant |
|---|---|
| Mean | 51.5 ± 13.4 |
| Sex: Female, Male(Participants) | Participant |
|---|---|
| Female | 51 |
| Male | 27 |
| Race (NIH/OMB)(Participants) | Participant |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 30 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 41 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Body Mass Index (BMI)(Kg/m^2) | Participant |
|---|---|
| Mean | 36.1 ± 10.1 |
| STOP-Bang(scores on a scale) | Participant |
|---|---|
| Mean | 3.9 ± 1.8 |
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University Hospitals Cleveland Medical Center