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

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Sleep Apnea Syndrome, Obstructive; Afib; CPAP

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT07087587

24-548

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Alternating CPAP vs. No Treatment

Experimental group

Description:

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.

Treatment:

Device: CPAP