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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UH-Participant 		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.
  • Device: Belun 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 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.

Recruiting Locations

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Ambrose A Chiang, MD
216-791-3800
Ambrose.Chiang@UHhospitals.org

More Details

Status
Recruiting
Sponsor
Belun Technology Company Limited

Study Contact

Ambrose A Chiang, MD
216-791-3800
Ambrose.Chiang@UHhospitals.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.