Treatment of obstructive sleep apnea reduces the risk of atrial fibrillation recurrence after catheter ablation.
Adam S Fein, Alexei Shvilkin, Dhaval Shah...
https://pubmed.ncbi.nlm.nih.gov/23623910Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06618417
National Virtual Trial Evaluating Home Sleep Apnea Testing in Patients with Atrial Fibrillation Using a Decentralized Platform
Led by Herlev and Gentofte Hospital · Updated on 2025-01-17
936
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether testing for sleep apnea at home can improve well-being in people with atrial fibrillation (an irregular heartbeat condition). The study involves about 936 participants who either will be tested for sleep apnea and treated if needed or will not be tested at all. The main goal is to see if those who are tested and possibly treated for sleep apnea have better quality of life scores after 18 weeks, measured by a specific questionnaire for atrial fibrillation. Participants will be randomly assigned in a 2:1 ratio to either receive a home-monitoring device for sleep apnea (WatchPAT One) along with a physical activity tracker (SENS Motion) or only the activity tracker. They will also use a smartphone app to monitor heart rhythm twice daily and report symptoms. The study is fully virtual and decentralized, with devices sent by mail and consultations done via video meetings. Participants undergo home monitoring for one night of sleep apnea testing (if in the intervention group) and two separate 7-day periods of activity tracking. If significant sleep apnea is detected, participants may be referred for clinical assessment and treatment. Throughout the study, participants complete digital questionnaires on quality of life, atrial fibrillation symptoms, sleep quality, and digital health literacy at different time points including baseline, 18 weeks, and a long-term follow-up after 9 months. Researchers monitor heart rhythm, physical activity, and symptoms using validated devices and apps. The study includes careful follow-up and support through phone and digital resources, aiming to evaluate the impact of home-based sleep apnea testing on well-being and heart health in atrial fibrillation patients.
CONDITIONS
Official Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Established diagnosis of paroxysmal or persistent atrial fibrillation
- Ownership of a compatible smartphone or willingness to use one provided by the investigators
- Understanding of possible sleep apnea treatment options including CPAP therapy
You will not qualify if you...
- Previous investigation for sleep-disordered breathing
- Advanced heart failure with left ventricular dysfunction and NYHA class III or IV
- Holding an occupational driver's license
- Pregnancy
- Current use of Doxazosin or Terazosin (alpha-adrenergic antagonists)
- Peripheral arterial disease causing daily intermittent claudication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Herlev-Gentofte Hospital
Hellerup, Denmark, 2900
Actively Recruiting
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Research Team
M
Morten Kjøbek Lamberts ML Associate Professor Lamberts
M
Mads Hashiba Jensen Hashiba, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Published Research Related To This Trial
Associations of Obstructive Sleep Apnea With Atrial Fibrillation and Continuous Positive Airway Pressure Treatment: A Review.
Dominik Linz, R Doug McEvoy, Martin R Cowie...
https://pubmed.ncbi.nlm.nih.gov/29541763Sleep-Disordered Breathing and Cardiac Arrhythmias in Adults: Mechanistic Insights and Clinical Implications: A Scientific Statement From the American Heart Association.
Reena Mehra, Mina K Chung, Brian Olshansky...
https://pubmed.ncbi.nlm.nih.gov/35912643A VIRTUAL Sleep Apnoea management pathway For the work-up of Atrial fibrillation patients in a digital Remote Infrastructure: VIRTUAL-SAFARI.
Dominique V M Verhaert, Konstanze Betz, Monika Gawałko...
https://pubmed.ncbi.nlm.nih.gov/34718525Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation.
John Spertus, Paul Dorian, Rosemary Bubien...
https://pubmed.ncbi.nlm.nih.gov/21160035Effect of sleep apnea and continuous positive airway pressure on cardiac structure and recurrence of atrial fibrillation.
Tomas G Neilan, Hoshang Farhad, John A Dodson...
https://pubmed.ncbi.nlm.nih.gov/24275628Safety and efficacy of pulmonary vein antral isolation in patients with obstructive sleep apnea: the impact of continuous positive airway pressure.
Dimpi Patel, Prasant Mohanty, Luigi Di Biase...
https://pubmed.ncbi.nlm.nih.gov/20689107Obstructive sleep apnea and the recurrence of atrial fibrillation.
Ravi Kanagala, Narayana S Murali, Paul A Friedman...
https://pubmed.ncbi.nlm.nih.gov/12743002The prevalence of obstructive sleep apnea in patients with atrial fibrillation.
Asmaa M Abumuamar, Paul Dorian, David Newman...
https://pubmed.ncbi.nlm.nih.gov/29745973Obstructive sleep apnea: implications for cardiac and vascular disease.
Abu S M Shamsuzzaman, Bernard J Gersh, Virend K Somers
https://pubmed.ncbi.nlm.nih.gov/14532320