Trial Outcomes & Findings for Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea (NCT NCT03997916)

NCT ID: NCT03997916

Last Updated: 2023-01-19

Results Overview

Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 113 participants
• Primary outcome timeframe: Same night when both testing were done on the same subject
• Results posted on: 2023-01-19

Participant Flow

Total of 336 subjects were screened, 130 subjects did not meet eligibility criteria. Out of the 206 subjects who were eligible, 93 refused to participate. Total of 113 subjects completed informed consent process and enrolled in the study.

Participant milestones

Measure	Participant 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 with the results of the PSG on the same patient. There will be no separate arm to test a different device. Belun Ring: 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 with the results of the PSG on the same patient. 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 with the results of the PSG on the same patient.
Overall Study STARTED	113
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Measure

Participant 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 with the results of the PSG on the same patient. There will be no separate arm to test a different device. Belun Ring: 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 with the results of the PSG on the same patient. 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 with the results of the PSG on the same patient.

Overall Study Protocol Violation

35

Baseline Characteristics

Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	Participant n=78 Participants 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 with the results of the PSG on the same patient. There will be no separate arm to test a different device. Belun Ring: 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 with the results of the PSG on the same patient. 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 with the results of the PSG on the same patient.
Age, Continuous	51.5 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	41 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Body Mass Index (BMI)	36.1 Kg/m^2 STANDARD_DEVIATION 10.1 • n=5 Participants
STOP-Bang	3.9 scores on a scale STANDARD_DEVIATION 1.8 • n=5 Participants

PRIMARY outcome

Timeframe: Same night when both testing were done on the same subject

Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

Outcome measures

Measure	Belun Ring Study Participants n=78 Participants Subjects that are eligible, willing to consent and completed the study with sufficient data for analysis
Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy) AHI cut off of 5	0.564 proportion of events Interval 0.447 to 0.676
Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy) AHI cut off of 15	0.808 proportion of events Interval 0.703 to 0.888
Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy) AHI cut off of 30	0.910 proportion of events Interval 0.824 to 0.963

PRIMARY outcome

Timeframe: Same night when both testing were done on the same subject

Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

Outcome measures

Measure	Belun Ring Study Participants n=78 Participants Subjects that are eligible, willing to consent and completed the study with sufficient data for analysis
Sensitivity AHI cut off at 5	1.000 proportion of events Interval 0.918 to 1.0
Sensitivity AHI cut off at 15	0.931 proportion of events Interval 0.772 to 0.992
Sensitivity AHI cut off at 30	0.714 proportion of events Interval 0.419 to 0.916

PRIMARY outcome

Timeframe: Same night when both testing were done on the same subject

Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

Outcome measures

Measure	Belun Ring Study Participants n=78 Participants Subjects that are eligible, willing to consent and completed the study with sufficient data for analysis
Specificity AHI cut off of 5	0.029 proportion of events Interval 0.001 to 0.149
Specificity AHI cut off of 15	0.735 proportion of events Interval 0.589 to 0.85
Specificity AHI cut off of 30	0.953 proportion of events Interval 0.869 to 0.99

Adverse Events

Belun Ring Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Yeh, MD

University Hospitals Cleveland Medical Center

Phone: 216-844-1867

Email: eric.yeh@uhhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place