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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Sanjay Rajnikant Patel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01187771
First received: August 23, 2010
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Obesity
Procedure: Laparoscopic Gastric Banding
Procedure: Continuous Positive Airway Pressure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Bariatric Surgery for the Treatment of Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Effective Apnea Hypopnea Index [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in Epworth Sleepiness Score [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean 24-hour Blood Pressure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Insulin Resistance (HOMA index) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Global Quality of Life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Depression (Patient Health Questionnaire-9) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Direct Health Care Costs [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic Gastric Banding Procedure: Laparoscopic Gastric Banding
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.
Active Comparator: Continuous Positive Airway Pressure Procedure: Continuous Positive Airway Pressure
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187771

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Sanjay Patel, M.D., M.S. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Sanjay Rajnikant Patel, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01187771     History of Changes
Other Study ID Numbers: R01 HL106410, RO1 HL106410
Study First Received: August 23, 2010
Last Updated: July 16, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014