Status:
WITHDRAWN
Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients
Lead Sponsor:
Stanford University
Conditions:
Obstructive Sleep Apnea
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
With this pilot study, we are hoping to test the feasibility of a larger study in the future and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial fibrillation af...
Detailed Description
Obstructive sleep apnea, a sleep-related breathing disorder in which breathing stops for short periods during sleep, is a common condition in patients with atrial fibrillation. Studies have shown that...
Eligibility Criteria
Inclusion
- Men and women 18 years or older
- First-time catheter ablation for atrial fibrillation
- Moderate-to-severe obstructive sleep apnea diagnosed with a sleep study (apnea-hypopnea index ≥ 15)
Exclusion
- Current or prior use of positive airway pressure for obstructive sleep apnea
- Any household member with current/past positive airway pressure use
- Did not meet minimal adherence to positive airway pressure treatment (≥ 4 hours/night and ≥ 70% of time in 2 weeks)
- History of motor vehicle or occupational accident related to excessive sleepiness
- Severe nocturnal desaturation documented on sleep study as \>10% of total sleep time with oxygen saturation of \< 75%
- Any condition determined by physicians that constrains the use of positive airway pressure such as anatomically fixed nasal obstruction, neurological impairment, and significant claustrophobia.
- Congestive heart failure (New York Heart Association IV)
- Severe valvular disease
- Planned coronary revascularization procedure in the next 6 months
- Severe pulmonary disease
- Participation in another treatment intervention trial that might influence results of this trial
- Ablation procedure scheduled in the next 8 weeks
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03242720
Start Date
January 1 2019
End Date
December 1 2020
Last Update
May 24 2022
Active Locations (1)
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1
Stanford Sleep Medicine Center
Redwood City, California, United States, 94063