Bariatric Surgery and Obstructive Sleep Apnea

NCT ID: NCT01243463

Last Updated: 2011-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea Bariatric Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Summa Health System

OTHER

Sponsor Role lead

Responsible Party

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Summa Health System

Locations

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Summa Health System Akron City Hospital

Akron, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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RP09125

Identifier Type: -

Identifier Source: org_study_id

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