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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital

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.

Eligibility criteria

Qualifiers

Established paroxysmal or persistent AF diagnosis

Owning a compatible smartphone

18 years or older

Disqualifiers

Previous investigation for sleep-disturbed breathing

Advanced heart failure (left ventricular dysfunction and NYHA III/IV)

Occupational driver licenses

Pregnancy

Trial design

Treatments tested in this trial

  • sleep apnea home-evaluation

Treatment groups

936 Participants
are divided into 2 treatment groups

Sponsors and collaborators