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

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea; Obesity
• Interventions: Procedure: Continuous Positive Airway Pressure; Procedure: Laparoscopic Gastric Banding

• Registration Number: NCT01187771
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Study Start: 2010-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2017-03-22
• Results First Submitted QC: 2017-05-26
• Results First Posted: 2017-07-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Severe sleep apnea with at least 1 referable symptom
• Obesity (BMI 35-45 kg/m2)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure	Continuous Positive Airway Pressure	-
Laparoscopic Gastric Banding	Laparoscopic Gastric Banding	-

Primary Outcome Measures

Name	Time	Method
Effective Apnea Hypopnea Index	9 months	The Effective Apnea Hypopnea Index (AHI) is the actual frequency of apneas and hypopneas per hour that the patient is exposed to. It is calculated as the AHI while on CPAP times the proportion of sleep time that CPAP was used plus the AHI off CPAP times the proportion of sleep time that CPAP is not used.
Epworth Sleepiness Score	9 months	The Epworth Sleepiness Scale results in scores ranging from 0-24, where scores of 0-10 indicate normal levels of sleepiness while 11-24 indicate excessive daytime sleepiness.

Secondary Outcome Measures

Name	Time	Method
Insulin Resistance (HOMA Index)	9 months
Calgary Sleep Apnea Quality of Life Index	9 months	The Calgary Sleep Apnea Quality of Life Index results in scores ranging from 1-7, with higher scores indicating a higher quality of life.
Direct Health Care Costs	9 months
Mean 24-hour Systolic Blood Pressure	9 months
Depression (Patient Health Questionnaire-9)	9 months	The PHQ-9 is scored from 0-27 with higher scores indicating more severe depression.
Mean 24-hour Diastolic Blood Pressure	9 months

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States