RECRUITINGINTERVENTIONAL

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

National Decentral/Virtual Randomized Trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Established paroxysmal or persistent AF diagnosis - Owning a compatible smartphone (or accepting a smart phone provided by the investigators) - Understanding of potential SA treatment possibilities including CPAP treatment Who Should NOT Join This Trial: - Previous investigation for sleep-disturbed breathing - Advanced heart failure (left ventricular dysfunction and NYHA III/IV) - Occupational driver licenses - Pregnancy - Doxazosin or Terazosin (alpha-adrenergic antagonists) - Peripheral arterial disease with daily intermittent claudication Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Established paroxysmal or persistent AF diagnosis * Owning a compatible smartphone (or accepting a smart phone provided by the investigators) * Understanding of potential SA treatment possibilities including CPAP treatment 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 (alpha-adrenergic antagonists) * Peripheral arterial disease with daily intermittent claudication

Treatments Being Tested

DEVICE

sleep apnea home-evaluation

Participants will receive a home-monitoring device by mail to test for sleep apnea at home

Locations (1)

Herlev-Gentofte Hospital

Hellerup, Denmark