Clinical trial NCT01187771: Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial
Official title: A Randomized Trial of Bariatric Surgery for the Treatment of Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Obesity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2010-08-24
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Effective Apnea Hypopnea Index
timeFrame: 9 months
measure: Epworth Sleepiness Score
timeFrame: 9 months
Secondary outcomes:
measure: Mean 24-hour Systolic Blood Pressure
timeFrame: 9 months
measure: Insulin Resistance (HOMA Index)
timeFrame: 9 months
measure: Calgary Sleep Apnea Quality of Life Index
timeFrame: 9 months
measure: Depression (Patient Health Questionnaire-9)
timeFrame: 9 months
measure: Direct Health Care Costs
timeFrame: 9 months
measure: Mean 24-hour Diastolic Blood Pressure
timeFrame: 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: University of Pittsburgh
name: Sanjay R Patel, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dudley KA, Tavakkoli A, Andrews RA, Seiger AN, Bakker JP, Patel SR. Interest in bariatric surgery among obese patients with obstructive sleep apnea. Surg Obes Relat Dis. 2015 Sep-Oct;11(5):1146-51. doi: 10.1016/j.soard.2015.01.006. Epub 2015 Jan 14.
citation: Bakker JP, Tavakkoli A, Rueschman M, Wang W, Andrews R, Malhotra A, Owens RL, Anand A, Dudley KA, Patel SR. Gastric Banding Surgery versus Continuous Positive Airway Pressure for Obstructive Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1080-1083. doi: 10.1164/rccm.201708-1637LE. No abstract available.