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

Not Applicable

Not yet recruiting

• Conditions: Afib; Sleep Apnea Syndrome, Obstructive; CPAP

• Registration Number: NCT07087587
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-08-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States