Afib, CPAP, Sleep Apnea Syndrome, Obstructive
Conditions
Keywords
OSA, CPAP, AFIB
Brief summary
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).
Detailed 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.
Interventions
DEVICECPAP
CPAP will be randomized 2 weeks on 2 weeks off for 12 weeks total
Sponsors
The Cleveland Clinic
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
N of 1 Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent 2. Age 18-85 years 3. High burden paroxysmal AF (≥1%) 4. Moderate-severe OSA (AHI ≥ 15) 5. Implanted device with atrial diagnostics 6. Enrolled in remote monitoring
Exclusion criteria
1. AF ablation \<6 months 2. Valvular abnormalities 3. Excessive daytime sleepiness in safety-critical jobs 4. Plans for ablation during study 5. Non-CPAP OSA treatment 6. Recent device implantation (\<6 months) 7. Central sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily AF Burden (%) | Up to 13 weeks (duration of each patient's participation) | Percentage change in average daily atrial fibrillation burden, measured via implantable device data, comparing CPAP and non-CPAP periods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Atrial Fibrillation-Related Quality of Life (AFEQT Score) | Baseline, week 4, week 8, and final visit (~13 weeks) | Change in patient-reported AFEQT scores between CPAP and non-CPAP periods to assess quality-of-life impact. |
Countries
United States
Contacts
CONTACTMina Chung, MD
CONTACTReena Mehra, MD
Outcome results
None listed