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

NCT01187771 | Completed Phase 2 Results DMC

• 1 other identifier: R01HL106410
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea; Obesity

Outcome Measures

Primary Outcomes (2)

• Effective Apnea Hypopnea Index

  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.

  9 months

• Epworth Sleepiness Score

  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.

  9 months

Secondary Outcomes (6)

• Mean 24-hour Systolic Blood Pressure

  9 months

• Insulin Resistance (HOMA Index)

  9 months

• Calgary Sleep Apnea Quality of Life Index

  9 months

• Depression (Patient Health Questionnaire-9)

  9 months

• Direct Health Care Costs

  9 months

Study Arms (2)

Laparoscopic Gastric Banding

ACTIVE COMPARATOR

Procedure: Laparoscopic Gastric Banding

Continuous Positive Airway Pressure

ACTIVE COMPARATOR

Procedure: Continuous Positive Airway Pressure

Interventions

Laparoscopic Gastric Banding PROCEDURE

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.

Laparoscopic Gastric Banding

Continuous Positive Airway Pressure PROCEDURE

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.

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• 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.

  PMID: 25892349 RESULT

• 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.

  PMID: 29035093 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Sanjay Patel
• Organization: University of Pittsburgh

patelsr2@upmc.edu

412-692-2035

Study Officials

• Sanjay R Patel, M.D., M.S.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 24, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 4, 2019
• Results First Posted: July 31, 2017

Record last verified: 2019-05

Locations

US (2)