Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor

NCT ID: NCT06255613

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2027-09-30

Brief Summary

Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA).

Primary Objective:

To rigorously evaluate the overall performance of the BR with Gen3 DL Algorithms and Subxiphoid Body Sensor in assessing SDB in individuals referred to the sleep labs with clinical suspicion of sleep apnea and a STOP-Bang score > 3, by comparing to the attended in-lab PSG, the gold standard.

Secondary Objectives:

To determine the accuracy of BR sleep stage parameters using the Gen3 DL algorithms by comparing to the in-lab PSG;

To assess the accuracy of the BR arrhythmia detection algorithm;

To assess the impact of CPAP on HRV (both time- and frequency-domain), delta HR, hypoxic burden, and PWADI during split night studies;

To assess if any of the baseline HRV parameters (both time- and frequency-domain), delta heart rate (referred to as Delta HR), hypoxic burden, and pulse wave amplitude drop index (PWADI) or the change of these parameters may predict CPAP compliance;

To evaluate the minimum duration of quality data necessary for BR to achieve OSA diagnosis;

To examine the performance of OSA screening tools using OSA predictive AI models formulated by National Taiwan University Hospital (NTUH) and Northeast Ohio Medical University (NEOMED).

Conditions

Sleep-Disordered Breathing; Sleep Architecture; Arrhythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

UH-Participant

Potential participants will be identified from patients scheduled for in-lab PSG at the two medical centers of University Hospitals

Group Type: EXPERIMENTAL

Belun Ring

Intervention Type: DEVICE

The Belun Ring sensor should be placed on the palmar side of the proximal phalanx of the index finger and the sensor should be placed along the radial artery such that the accuracy of the device will be minimally affected by skin color. The Ring has 7 adjustable arms for different finger sizes. Each device is reusable after thorough cleaning with an alcohol swab.

Belun Cor

Intervention Type: DEVICE

The "Belun Cor" body sensor accessory is composed of an accelerometer, a temperature sensor, and a lithium battery. It will be placed immediately below the xiphoid process in the upper abdomen with a medical adhesive to detect the body temperature, body posture, respiratory rate, and respiratory efforts.

Interventions

Belun Ring

The Belun Ring sensor should be placed on the palmar side of the proximal phalanx of the index finger and the sensor should be placed along the radial artery such that the accuracy of the device will be minimally affected by skin color. The Ring has 7 adjustable arms for different finger sizes. Each device is reusable after thorough cleaning with an alcohol swab.

Intervention Type: DEVICE

Belun Cor

The "Belun Cor" body sensor accessory is composed of an accelerometer, a temperature sensor, and a lithium battery. It will be placed immediately below the xiphoid process in the upper abdomen with a medical adhesive to detect the body temperature, body posture, respiratory rate, and respiratory efforts.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Provision of signed informed consent form.
• Clinically assessed and suspicious for OSA with a STOP-Bang score ≥ 3.

Exclusion Criteria

• Full night PAP titration study.
• On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of a nerve stimulator.
• Having atrial fibrillation-flutter, pacemaker/defibrillator, left ventricular assist device (LVAD), or status post cardiac transplantation.
• 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.

If a participant did not sleep for at least 4 hours of technically valid sleep based on the Belun Ring method for diagnostic assessments, or a minimum of 3 hours of technically valid sleep during the diagnostic phase of a split-night study, the patient will be excluded from statistical analysis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

Belun Technology Company Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ambrose A. Chiang, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Susheel P. Patil, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Kingman P. Strohl, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

UH Geauga Health Center Services

Chardon, Ohio, United States

Site Status: RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tiffany Tsai

Role: CONTACT

tiffany.tsai2@va.gov

216-844-3201

Facility Contacts

Ambrose A Chiang, MD

Role: primary

Ambrose A Chiang, MD

Role: primary

Ambrose.Chiang@UHhospitals.org

216-791-3800 ext. 62976

Other Identifiers

STUDY20231436

Identifier Type: -

Identifier Source: org_study_id