Bariatric Surgery and Obstructive Sleep Apnea
BAROSA
Effects of Bariatric Surgery on Obstructive Sleep Apnea
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 18, 2010
CompletedJuly 21, 2011
July 1, 2011
November 16, 2010
July 20, 2011
Conditions
Eligibility Criteria
Obese women, 20 - 85 years of age
You may qualify if:
- 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
You may not qualify if:
- are excluded if failure to meet any of the above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Summa Health System Akron City Hospital
Akron, Ohio, 44304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 18, 2010
Study Start
February 1, 2010
Last Updated
July 21, 2011
Record last verified: 2011-07