Home testing for sleep apnea to improve well-being in patients with atrial fibrillation
National Decentral/Virtual Randomized Trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation
This study is testing if home testing and treatment for sleep apnea can help people with atrial fibrillation feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 936 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT06618417 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether home-based testing for sleep apnea can enhance the well-being of individuals diagnosed with atrial fibrillation. Approximately 936 participants will be randomly assigned to either receive sleep apnea testing and treatment or not receive any testing. The study will track participants' well-being and heart-related symptoms through a mobile app over 18 weeks, measuring quality of life improvements using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. The hypothesis is that those tested and treated for sleep apnea will show a significant improvement in their quality of life scores compared to those who are not tested.
Who should consider this trial
Good fit: Ideal candidates include individuals with established paroxysmal or persistent atrial fibrillation who own a compatible smartphone.
Not a fit: Patients with advanced heart failure, previous investigations for sleep-disturbed breathing, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life and health outcomes for patients with atrial fibrillation by effectively managing sleep apnea.
How similar studies have performed: Other studies have indicated the importance of managing sleep apnea in patients with atrial fibrillation, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hellerup
- Herlev-Gentofte Hospital — Hellerup, Denmark (Recruiting)
Study contacts
- Study coordinator: Morten Kjøbek Lamberts ML Associate Professor Lamberts
- Email: morten.kjoebek.lamberts@regionh.dk
- Phone: +45 22434186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.