Phase 2 N=49 Randomized Single-blind Treatment

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

Obstructive Sleep Apnea · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01187771 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Jul 2017

Primary outcome: Primary: Effective Apnea Hypopnea Index — 29.5; 20.0 Events per hour

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Laparoscopic Gastric Banding (Procedure); Continuous Positive Airway Pressure (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Effective Apnea Hypopnea Index	29.5; 20.0	—
PRIMARY Epworth Sleepiness Score	7.6; 7.8	—
SECONDARY Mean 24-hour Systolic Blood Pressure	121.7; 119.5	—
SECONDARY Insulin Resistance (HOMA Index)	—	—
SECONDARY Calgary Sleep Apnea Quality of Life Index	4.8; 4.4	—
SECONDARY Depression (Patient Health Questionnaire-9)	4.0; 6.2	—
SECONDARY Direct Health Care Costs	—	—
SECONDARY Mean 24-hour Diastolic Blood Pressure	75.8; 74.9	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01187771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.