Status:
COMPLETED
Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery
Lead Sponsor:
Laval University
Collaborating Sponsors:
GROUPE DE RECHERCHE EN SANTÉ RESPIRATOIRE DE L'UNIVERSITÉ LAVAL (GESER)
Conditions:
Obstructive Sleep Apnea
Treatment Compliance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation and sleep micr...
Eligibility Criteria
Inclusion
- Obese patients with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with additional risk factors for cardiovascular disease and eligible for bariatric surgery;
- Laparoscopic bariatric surgery planned in 2-6 months. Procedures include biliopancreatic diversion with duodenal switch and sleeve gastrectomy;
- Recent diagnosis of obstructive sleep apnea made by a sleep study. The sleep study must be a overnight pulse oximetry showing a 3% desaturation index ≥ 25/hour or a polysomnography with a apnea + hypopnea index (AHI) ≥ 25/hour\* ;
- No previous use of positive airway pressure device;
- ≥18 year old.
Exclusion
- Severe comorbidities (respiratory, cardiac, neurologic or metabolic unstable disease);
- Central sleep apnea;
- Obesity hypoventilation syndrome;
- Planned bariatric surgery by laparotomy;
- Contraindications to positive airway pressure therapy: pneumothorax within the preceding 6 months, cerebrospinal fluid leak, cranial surgery or trauma within the last year.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 16 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02209220
Start Date
September 1 2014
End Date
March 16 2018
Last Update
August 5 2019
Active Locations (1)
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1
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5