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

April 9, 2026 updated by: Mina Chung, MD, The Cleveland Clinic
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Reena Mehra, MD
  • Phone Number: 216-272-7405
  • Email: mehrar@uw.edu

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
    • Washington
      • Seattle, Washington, United States, 98195
        • Not yet recruiting
        • University of Washington
        • Contact:
          • Reena Mehra, MD
          • Phone Number: 216-272-7405
          • Email: mehrar@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alternating CPAP vs. No Treatment
Each participant undergoes alternating 2-week periods of CPAP treatment and no treatment over approximately 13 weeks. This personalized intervention evaluates changes in AF burden and quality of life, with patients serving as their own controls.
Device: CPAP
CPAP will be randomized 2 weeks on 2 weeks off for 12 weeks total

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 13 weeks (duration of each patient's participation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 4, week 8, and final visit (~13 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 18, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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