RECRUITING

Belun Ring Platform With an Improved Algorithm for OSA Assessment

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Conditions

Sleep-Disordered BreathingSleep ArchitectureObstructive Sleep ApneaWearableHome Sleep Apnea TestingPhotoplethysmographyValidationArtificial Intelligence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-02-01
Study Completion:2022-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04885062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form.
  2. * Age 18-80
  3. * Clinically assessed and suspicious for OSA
  1. * Full night PAP titration study
  2. * On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
  3. * Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF \< 55%, left ventricular assist device (LVAD), or status post cardiac transplantation
  4. * Patients taking narcotics
  5. * Recent hospitalization or recent surgery in the past 30 days
  6. * 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

Contacts and Locations

Study Contact

Ambrose A Chiang, MD
CONTACT
216-791-3800
Ambrose.Chiang@UHhospitals.org
Zachary Strumpf, MD
CONTACT
zachary.strumpf@UHhospitals.org

Principal Investigator

Ambrose A Chiang, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Belun Technology Company Limited

  • Ambrose A Chiang, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01
Study Completion Date2022-06-30

Study Record Updates

Study Start Date2021-02-01
Study Completion Date2022-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Sleep-Disordered Breathing
  • Sleep Architecture