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NCT07087587NARecruiting

Sleep Apnea Triggers of Atrial Fibrillation: N-of-1 Randomized Control Trial (SPARTA):

The Cleveland Clinic

Start Date

8/25/2025

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

DEVICE

CPAP

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Conditions

AfibSleep Apnea Syndrome, ObstructiveCPAP

Locations

Cleveland Clinic

Cleveland, Ohio 44195

United States

University of Washington

Seattle, Washington 98195

United States