Screening and treating sleep apnea in people with atrial fibrillation who are candidates for ablation
Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates
This program will try screening for and treating sleep apnea in adults with atrial fibrillation that persists despite medication to see if treating sleep apnea lowers arrhythmia burden and reduces the need for ablation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT04606693 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized cohort that uses the Stop-Bang questionnaire to stratify AF patients by risk of sleep apnea. Patients at intermediate or high risk receive home respiratory polygraphy and use a Kardia recorder to track cardiac rhythm before and during treatment. Those diagnosed with sleep apnea receive standard therapies (lifestyle measures, CPAP, etc.) from Pneumology and continue rhythm monitoring for three months. After follow-up the arrhythmic load is re-evaluated to determine which patients still require ablation versus those who can be managed with follow-up.
Who should consider this trial
Good fit: Adults with paroxysmal or persistent atrial fibrillation that recurs despite at least one class I or III antiarrhythmic and no prior diagnosis of sleep apnea are eligible.
Not a fit: Patients without sleep-disordered breathing, those unable to perform home testing or use the smartphone-based recorder, or those whose AF is unrelated to sleep apnea may not benefit.
Why it matters
Potential benefit: If successful, treating sleep apnea could reduce arrhythmia burden and lower the number of patients who need AF ablation.
How similar studies have performed: Observational studies have suggested that treating obstructive sleep apnea can reduce AF recurrence and improve outcomes, though randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with paroxysmal or persistent atrial fibrillation * Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic * No previous diagnosis of apnea-hypopnea syndrome Exclusion Criteria: * Patients \<18 years * Pregnant women * Doubts about the patient's ability to perform a home respiratory polygraphy * Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required) * Unavailability for follow-up at our center for at least 1 year.
Where this trial is running
Madrid, Madrid
- Hospital Clínico San Carlos — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Nicasio Pérez-Castellano, MD PhD
- Email: nicasio.perez@salud.madrid.org
- Phone: +34913303000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.