Recruiting

CPAP

Sponsor:

The Cleveland Clinic

Code:

NCT07087587

Conditions

Afib

Sleep Apnea Syndrome, Obstructive

CPAP

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CPAP

Study Details

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

Sleep Apnea Syndrome, Obstructive

CPAP

Study ID

NCT07087587

Start date

Aug 25, 2025

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

CPAP

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

Primary outcome measure

  • Change in Average Daily AF Burden (%) [ Time Frame: Up to 13 weeks (duration of each patient's participation) ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

The Cleveland Clinic

Last update posted

Apr 13, 2026

Last verified

Oct, 2025

Keywords

  • OSA
  • CPAP
  • AFIB

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-04-13.