Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial

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.

Inclusion Criteria:

- Severe sleep apnea with at least 1 referable symptom

- Obesity (BMI 35-45 kg/m2)

Exclusion Criteria:

- 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