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Belun Ring Platform With an Improved Algorithm for OSA Assessment

Primary Purpose

Sleep-Disordered Breathing, Sleep Architecture

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Belun Ring

PSG

About this trial

This is an interventional diagnostic trial for Sleep-Disordered Breathing focused on measuring Obstructive Sleep Apnea, Wearable, Home Sleep Apnea Testing, Photoplethysmography, Validation, Artificial Intelligence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UH-Participant

Arm Description

Potential participants with suspected OSA will be identified from the schedule of the UH Beachwood and Bolwell sleep labs.Those subjects who satisfy the study inclusion and exclusion criteria will be approached and invited to participate in the study.

Outcomes

Primary Outcome Measures

REI parameters

To determine the overall accuracy, sensitivity, and specificity of the BLS-100 in assessing OSA by comparing to the attended in-lab PSG in individuals referred to the sleep labs with clinical suspicion of OSA.

Secondary Outcome Measures

Sleep stage parameters

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.

Full Information

NCT ID

NCT04885062

First Posted

May 4, 2021

Last Updated

July 19, 2021

Sponsor

Belun Technology Company Limited

Collaborators

University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04885062

Brief Title

Belun Ring Platform With an Improved Algorithm for OSA Assessment

Official Title

Belun Ring Platform (BLS-100) Home Sleep Apnea Testing Device With an Improved Algorithm for Assessment of Obstructive Sleep Apnea: A Comparison to In-Lab Polysomnography

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

August 30, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Belun Technology Company Limited

Collaborators

University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep-Disordered Breathing, Sleep Architecture

Keywords

Obstructive Sleep Apnea, Wearable, Home Sleep Apnea Testing, Photoplethysmography, Validation, Artificial Intelligence

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UH-Participant

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Belun Ring

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

PSG

Intervention Description

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.

Primary Outcome Measure Information:

Title

REI parameters

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Sleep stage parameters

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ambrose A Chiang, MD

Phone

216-791-3800

Ext

62976

Ambrose.Chiang@UHhospitals.org

First Name & Middle Initial & Last Name or Official Title & Degree

Zachary Strumpf, MD

zachary.strumpf@UHhospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ambrose A Chiang, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ambrose A Chiang, MD

Phone

216-791-3800

Ext

62976

Ambrose.Chiang@UHhospitals.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Belun Ring Platform With an Improved Algorithm for OSA Assessment

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