- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01243463
Bariatric Surgery and Obstructive Sleep Apnea (BAROSA)
July 20, 2011 updated by: Summa Health System
Effects of Bariatric Surgery on Obstructive Sleep Apnea
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Akron, Ohio, United States, 44304
- Summa Health System Akron City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Obese women, 20 - 85 years of age
Description
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
Exclusion Criteria:
- are excluded if failure to meet any of the above
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Study Registration Dates
First Submitted
November 16, 2010
First Submitted That Met QC Criteria
November 17, 2010
First Posted (Estimate)
November 18, 2010
Study Record Updates
Last Update Posted (Estimate)
July 21, 2011
Last Update Submitted That Met QC Criteria
July 20, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP09125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
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Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
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LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
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University of California, Los AngelesRecruiting
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Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
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State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
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The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia