Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial
Condition: Obstructive Sleep Apnea; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

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.
    

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 predisposing to hypertension, insulin resistance, diabetes, cardiovascular
      disease, and stroke. The current first line treatment for moderate to severe OSA, nasal
      continuous positive airway pressure (CPAP) is extremely effective but is often not well
      tolerated, leading to low adherence rates in many patients. Bariatric surgery has been
      approved as treatment for OSA in patients with co-morbid obesity and in small studies,
      appears to produce substantial improvements. However, no trials directly comparing bariatric
      procedures with standard CPAP treatment yet exist to guide clinicians and patients in
      choosing the most appropriate first line treatment. This trial will address the feasibility
      and safety, and estimate the effect sizes for a subsequent Phase 3 trial. We will recruit 80
      patients with severe OSA and morbid obesity (body mass index, BMI, of 35-45 kg/m2) from two
      large clinical sleep programs that together care for a wide spectrum and demographically
      diverse group of OSA patients. After establishing patient and physician equipoise, subjects
      will be randomized to a trial of CPAP or laparoscopic gastric banding as first line treatment
      for OSA. The primary outcome measures will be improvement in OSA severity under both ideal
      and real life conditions (i.e., in the CPAP arm, while using CPAP in a controlled environment
      vs. while using prescribed therapy in the usual home environment, respectively), which will
      allow for assessments of both comparative efficacy and effectiveness. Outcomes will be
      assessed at 9 months to quantify the early effectiveness of each treatment strategy as well
      as to demonstrate clinical equipoise in conducting a future larger long term trial using
      these two arms. Further follow-up will occur at 18 months in a subset of 40 patients to
      determine effect sizes for the subsequent study at a point where the bariatric arm has neared
      a plateau in weight. Secondary outcomes will include patient-related outcomes including
      sleepiness, quality of life, and an index of health service utilization. In addition, changes
      in biomarkers related to inflammation, insulin resistance, lipids, blood pressure, and
      arterial stiffness will be assessed in each group, and in relationship to changes in BMI and
      OSA, to identify promising outcome measures for future trials. Incurred costs will be
      collected in all subjects in order to establish the parameters needed for a cost
      effectiveness analysis. This pilot study will represent the first controlled comparison of
      medical and surgical treatments for OSA and in addition, will provide the necessary data to
      develop the optimal study design for a subsequent long term multi-center comparative
      effectiveness study to better understand the potential role that bariatric surgery may offer
      in the management of OSA.
    

Intervention name(s): Laparoscopic Gastric Banding; Continuous Positive Airway Pressure
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment