Obstructive Sleep Apnea Clinical Trial
— BAROSAOfficial title:
Effects of Bariatric Surgery on Obstructive Sleep Apnea
NCT number | NCT01243463 |
Other study ID # | RP09125 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | November 16, 2010 |
Last updated | July 20, 2011 |
Start date | February 2010 |
Verified date | July 2011 |
Source | Summa Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 85 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Summa Health System Akron City Hospital | Akron | Ohio |
Lead Sponsor | Collaborator |
---|---|
Summa Health System |
United States,
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