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NCT Number: NCT07087587

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

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).

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Key information

Conditions

Afib Apnea Arrhythmias, Cardiac Atrial Fibrillation CPAP Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndrome, Obstructive Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

CPAP will be randomized 2 weeks on 2 weeks off for 12 weeks total

Primary outcomes

  1. Change in Average Daily AF Burden (%)

    Time frame: 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 outcomes

  1. Change in Atrial Fibrillation-Related Quality of Life (AFEQT Score)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mina Chung, MD

CONTACT

[email protected]

2164442290

Reena Mehra, MD

CONTACT

[email protected]

216-272-7405

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • University of Washington

Registry information

Acronym: SPARTA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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