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

NCT ID: NCT07087587

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Afib Sleep Apnea Syndrome, Obstructive CPAP

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

N of 1 Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

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

Interventions

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CPAP

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mina Chung, MD

Staff of Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Mina Chung, MD

Role: CONTACT

2164442290

Reena Mehra, MD

Role: CONTACT

216-272-7405

Facility Contacts

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Reena Mehra, MD

Role: primary

216-272-7405

References

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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.

Reference Type BACKGROUND
PMID: 35912643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33938787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30522886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12743002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31300334 (View on PubMed)

Other Identifiers

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24-548

Identifier Type: -

Identifier Source: org_study_id

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