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RECRUITING Not applicable ClinicalTrials.gov

Evaluating the Impact of Home-Based Sleep Apnea Diagnostic on Well-Being, Health Behavior, and AF Load in Patients With Atrial Fibrillation Using a Decentralized Platform

Sponsor: Herlev and Gentofte Hospital • ClinicalTrials.gov ID: NCT06618417

Registry updated: 2026-08-26
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Description

The goal of this clinical trial is to find out if testing for sleep apnea (a condition where breathing stops and starts during sleep) at home can improve well-being in people with atrial fibrillation (an irregular heartbeat condition). About 936 participants will be involved. They will either be tested for sleep apnea and treated, if needed, or not tested at all. Researchers will compare the well-being and heart-related symptoms of participants who are tested for sleep apnea to those who are not. These will be tracked using a mobile app to monitor symptoms, physical activity, and heart rhythm. Main hypothesis: Participants with atrial fibrillation who are tested and possibly treated for sleep apnea will have improved quality of life scores (measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire) by at least 5 points after 18 weeks.

Interventions

  • sleep apnea home-evaluation (Device)
    Participants will receive a home-monitoring device by mail to test for sleep apnea at home

Eligibility criteria

Inclusion Criteria: * Established paroxysmal or persistent AF diagnosis * Owning a compatible smartphone * 18 years or older Exclusion Criteria: * Previous investigation for sleep-disturbed breathing * Advanced heart failure (left ventricular dysfunction and NYHA III/IV) * Occupational driver licenses * Pregnancy * Doxazosin or Terazosin treatment (alpha-adrenergic antagonists) * Peripheral arterial disease with daily intermittent claudication

Conditions

Atrial Fibrillation (AF) Sleep Apnea

Locations

  • Herlev-Gentofte Hospital — Hellerup, Denmark
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record