At a glance
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A Randomized Trial of Bariatric Surgery for the Treatment of Sleep Apnea
In Brief
A Phase 2 clinical trial evaluating Laparoscopic Gastric Banding and Continuous Positive Airway Pressure for Obstructive Sleep Apnea and Obesity. Completed, enrolled 53 participants across 2 sites.
Detailed 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 (OSA) in the setting of obesity.
Study Details
Timeline
Interventions
Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.