Bariatric Surgery and Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— BAROSA  

Official title:

Effects of Bariatric Surgery on Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243463
• Other study ID #: RP09125
• Status: Completed
• Phase: N/A
• First received: November 16, 2010
• Last updated: July 20, 2011
• Start date: February 2010

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Bariatric Surgery
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Summa Health System Akron City Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Summa Health System

Country where clinical trial is conducted

United States,