Status:
COMPLETED
Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Conditions:
Obstructive Sleep Apnea
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the feasibility of conducting a comparative effectiveness study comparing a medical versus surgical approach to the initial management of obstructive sleep apnea...
Detailed Description
Obstructive sleep apnea (OSA) is one of the most common complications of obesity, resulting in excessive sleepiness and daytime functional impairment as well as acting synergistically with obesity in ...
Eligibility Criteria
Inclusion
- Severe sleep apnea with at least 1 referable symptom
- Obesity (BMI 35-45 kg/m2)
Exclusion
- Prior use of CPAP within the last two years or prior bariatric surgery
- Hypoxemia or hypercapnia
- Elevated peri-operative risk
- Drowsy driving in past year
- Unstable medical or psychiatric conditions
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01187771
Start Date
November 1 2010
End Date
December 1 2014
Last Update
June 4 2019
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215