RecruitingNot ApplicableNCT06618417

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


Sponsor

Herlev and Gentofte Hospital

Enrollment

936 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

Interventions

DEVICEsleep 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

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NCT06618417


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