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

NCT07087587 | Recruiting

• 1 other identifier: 24-548
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

Afib; CPAP; Sleep Apnea Syndrome, Obstructive

Keywords

OSA; CPAP; AFIB

Outcome Measures

Primary Outcomes (1)

• Change in Average Daily AF Burden (%)

  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 Outcomes (1)

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

  Baseline, week 4, week 8, and final visit (~13 weeks)

Study Arms (1)

Alternating CPAP vs. No Treatment

EXPERIMENTAL

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

Interventions

CPAP DEVICE

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

Alternating CPAP vs. No Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of Washington: collaborator

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

NOT YET RECRUITING

Related Publications (5)

• Mehra R, Chung MK, Olshansky B, Dobrev D, Jackson CL, Kundel V, Linz D, Redeker NS, Redline S, Sanders P, Somers VK; American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology; and Stroke Council. Sleep-Disordered Breathing and Cardiac Arrhythmias in Adults: Mechanistic Insights and Clinical Implications: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 30;146(9):e119-e136. doi: 10.1161/CIR.0000000000001082. Epub 2022 Aug 1.

  PMID: 35912643 BACKGROUND

• Traaen GM, Aakeroy L, Hunt TE, Overland B, Bendz C, Sande LO, Aakhus S, Fagerland MW, Steinshamn S, Anfinsen OG, Massey RJ, Broch K, Ueland T, Akre H, Loennechen JP, Gullestad L. Effect of Continuous Positive Airway Pressure on Arrhythmia in Atrial Fibrillation and Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2021 Sep 1;204(5):573-582. doi: 10.1164/rccm.202011-4133OC.

  PMID: 33938787 BACKGROUND

• Caples SM, Mansukhani MP, Friedman PA, Somers VK. The impact of continuous positive airway pressure treatment on the recurrence of atrial fibrillation post cardioversion: A randomized controlled trial. Int J Cardiol. 2019 Mar 1;278:133-136. doi: 10.1016/j.ijcard.2018.11.100. Epub 2018 Nov 20.

  PMID: 30522886 BACKGROUND

• Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.

  PMID: 12743002 BACKGROUND

• Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

  PMID: 31300334 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Mina Chung, MD

CONTACT

2164442290; CHUNGM@ccf.org

Reena Mehra, MD

CONTACT

216-272-7405; mehrar@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff of Cardiovascular Medicine

Model Details: N of 1 Study

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 28, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)