Sleep Apnea Triggers of Atrial Fibrillation: N-of-1 Randomized Control Trial (SPARTA):
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Cleveland Clinic
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent
Age 18-85 years
High burden paroxysmal AF (≥1%)
Moderate-severe OSA (AHI ≥ 15)
Disqualifiers
AF ablation <6 months
Valvular abnormalities
Excessive daytime sleepiness in safety-critical jobs
Plans for ablation during study
Trial design
Design model
Single group
Treatments tested in this trial
CPAP
DeviceCPAP will be randomized 2 weeks on 2 weeks off for 12 weeks total
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Alternating CPAP vs. No TreatmentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to 13 weeks (duration of each patient's participation)Secondary outcomes
1
Change in Atrial Fibrillation-Related Quality of Life (AFEQT Score)
Change in patient-reported AFEQT scores between CPAP and non-CPAP periods to assess quality-of-life impact.
Time frame
Baseline, week 4, week 8, and final visit (~13 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
University of Washington
Collaborator
Source ClinicalTrials.gov