Overview
A pilot N-of-1 randomized controlled trial evaluating the effectiveness of a personalized CPAP intervention in reducing atrial fibrillation (AF) burden and improving AF-related quality of life in patients with moderate to severe obstructive sleep apnea (OSA).
Description
This pilot study investigates whether continuous positive airway pressure (CPAP) therapy reduces AF burden in patients with paroxysmal AF and moderate to severe OSA. Using an N-of-1 randomized crossover design, each participant undergoes alternating 2-week periods with and without CPAP over 3 months. Data on AF episodes are collected from implantable cardiac devices, and AF-related quality of life is assessed using the AFEQT questionnaire. The study also examines CPAP adherence and its correlation with changes in AF burden. Results will inform the design of a larger trial and address gaps in current evidence on the cardiovascular effects of sleep apnea therapy.
Eligibility
Inclusion Criteria:
- Informed consent
- Age 18-85 years
- High burden paroxysmal AF (≥1%)
- Moderate-severe OSA (AHI ≥ 15)
- Implanted device with atrial diagnostics
- Enrolled in remote monitoring
Exclusion Criteria:
- AF ablation <6 months
- Valvular abnormalities
- Excessive daytime sleepiness in safety-critical jobs
- Plans for ablation during study
- Non-CPAP OSA treatment
- Recent device implantation (<6 months)
- Central sleep apnea