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NCT06618417Recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
936 (estimated)
First submitted
19 Sept 2024
Start date
5 Dec 2024
Primary completion date
1 Feb 2027
Lead sponsor
Herlev and Gentofte Hospital
NCT number
NCT06618417

What you commit to

  • Study type: Interventional
  • Planned participants: 936
  • From 5 Dec 2024 to the primary completion date, 1 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous investigation for sleep-disturbed breathing

Other illness

  • Advanced heart failure (left ventricular dysfunction and NYHA III/IV)
  • Peripheral arterial disease with daily intermittent claudication

Other

  • Occupational driver licenses
  • Pregnancy
  • Doxazosin or Terazosin treatment (alpha-adrenergic antagonists)

Who the study is looking for

  • Established paroxysmal or persistent AF diagnosis
  • Owning a compatible smartphone
  • 18 years or older

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Herlev-Gentofte Hospital
Coordinator of this site? Confirm its status
HellerupDenmarkRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.