NCT06618417 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
| NCT ID | NCT06618417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herlev and Gentofte Hospital |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 936 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 936 participants in total. It began in 2024-12-05 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Morten Kjøbek Lamberts ML Associate Professor Lamberts
✉ morten.kjoebek.lamberts@regionh.dk📞 +45 22434186
Frequently Asked Questions
Who can join the NCT06618417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06618417 currently recruiting?
Yes, NCT06618417 is actively recruiting participants. Contact the research team at morten.kjoebek.lamberts@regionh.dk for enrollment information.
Where is the NCT06618417 trial being conducted?
This trial is being conducted at Hellerup, Denmark.
Who is sponsoring the NCT06618417 clinical trial?
NCT06618417 is sponsored by Herlev and Gentofte Hospital. The trial plans to enroll 936 participants.
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