Bariatric Surgery and Obstructive Sleep Apnea (BAROSA)

This study has been completed.
Sponsor:
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT01243463
First received: November 16, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition
Obstructive Sleep Apnea
Bariatric Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Bariatric Surgery on Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Summa Health System:

Estimated Enrollment: 20
Study Start Date: February 2010
  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obese women, 20 - 85 years of age

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243463

Locations
United States, Ohio
Summa Health System Akron City Hospital
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
  More Information

No publications provided

Responsible Party: Rachael Pohle-Krauza, Summa Health System
ClinicalTrials.gov Identifier: NCT01243463     History of Changes
Other Study ID Numbers: RP09125
Study First Received: November 16, 2010
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014