Sleep Apnea Triggers of Atrial Fibrillation: N-of-1 Randomized Control Trial (SPARTA):
Recruiting · NCT07087587 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
CPAP
What this trial is about
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).
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 2 US states.
- Cleveland Clinic - Cleveland, Ohio, United States
- University of Washington - Seattle, Washington, United States