Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial (ABC)
|ClinicalTrials.gov Identifier: NCT01187771|
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Obesity||Procedure: Laparoscopic Gastric Banding Procedure: Continuous Positive Airway Pressure||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Trial of Bariatric Surgery for the Treatment of Sleep Apnea|
|Study Start Date :||November 2010|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
|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.
- Effective Apnea Hypopnea Index [ Time Frame: 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 [ Time Frame: 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.
- Mean 24-hour Systolic Blood Pressure [ Time Frame: 9 months ]
- Insulin Resistance (HOMA Index) [ Time Frame: 9 months ]
- Calgary Sleep Apnea Quality of Life Index [ Time Frame: 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.
- Depression (Patient Health Questionnaire-9) [ Time Frame: 9 months ]The PHQ-9 is scored from 0-27 with higher scores indicating more severe depression.
- Direct Health Care Costs [ Time Frame: 9 months ]
- Mean 24-hour Diastolic Blood Pressure [ Time Frame: 9 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187771
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sanjay Patel, M.D., M.S.||University of Pittsburgh|