Phase 2
Completed N=49
Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial
Source: ClinicalTrials.gov NCT01187771 ↗Enrolled (actual)
49
Serious AEs
14.3%
Results posted
Jul 2017
Primary outcomePrimary: Effective Apnea Hypopnea Index — 29.5; 20.0 Events per hour
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.
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 | — |
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
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. Informational only — not medical advice.