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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether testing patients with atrial fibrillation (an irregular heartbeat) for sleep apnea at home — using a decentralized digital platform — can improve their wellbeing, health behaviors, and how often their heart goes back into an irregular rhythm. Sleep apnea is common in people with AF and can make it harder to treat. **You may be eligible if...** - You have been diagnosed with paroxysmal (comes and goes) or persistent atrial fibrillation - You own a compatible smartphone (or are willing to use one provided by the study) - You understand what sleep apnea is and are open to treatment options like CPAP **You may NOT be eligible if...** - You have already been tested or treated for sleep-disordered breathing - You have advanced heart failure with severely reduced heart function (NYHA Class III or IV) - You hold an occupational driver's license - You are pregnant - You take certain alpha-blocking medications (doxazosin or terazosin) - You have peripheral artery disease with daily pain when walking Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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