Bariatric Surgery and Obstructive Sleep Apnea

Completed

• Conditions: Obstructive Sleep Apnea; Bariatric Surgery

• Registration Number: NCT01243463
• Lead Sponsor: Summa Health System

Brief Summary

More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two conditions separately, and these treatment modalities both present a unique set of challenges in terms of patient-adherence. Furthermore, the combined effects of these therapies on body weight and OSA severity are unclear, and require longitudinal investigation. The purpose of the research proposed herein is twofold: A) To prospectively demonstrate the specific physiologic/psychological improvements in OSA risk factors and disease severity that occur in a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss, dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or non-compliant with prescribed PAP therapy. The investigators anticipate that results will be used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in bariatric surgery patients. Furthermore, this line of research has many implications for strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and other clinical sub-specialties that are integral to the postoperative health of these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• obese (Body Mass Index > 35)
• pending laparoscopic roux-en-Y gastric bypass at Summa Bariatric Care Center
• women
• ages 20 - 85
• diagnosed OSA and prescribed nocturnal, autotitrating positive airway pressure therapy

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Exclusion Criteria

• are excluded if failure to meet any of the above

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Summa Health System Akron City Hospital; 🇺🇸 Akron, Ohio, United States