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The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA) (OSA)

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ClinicalTrials.gov Identifier: NCT01573676
Recruitment Status : Unknown
Verified April 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2012
Last Update Posted : April 9, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep breathing disorders in patients with extreme BMI.

Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The characteristics of patients with sleep apnea that were evaluated for bariatric surgery and had a full overnight polysomnography (PSG) screening for OSA were described and it was found that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.

The investigators would like to demonstrate the impact of bariatric surgery on OSA as a function of time.


Condition or disease
Overweight Obstructive Sleep Apnea

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA)
Study Start Date : May 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Bariatric surgery patients
Candidates for bariatric surgery.


Outcome Measures

Primary Outcome Measures :
  1. Improvement in RDI after bariatric surgery [ Time Frame: Six months ]
    Improvement will measured by polysonography


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
both males and females
Criteria

Inclusion Criteria:

  • All candidates for bariatric surgery over 18 yrs of age

Exclusion Criteria:

  • Patients that underwent any OSA surgery in the past
  • Patient had any bariatric surgery in the past
  • Patients with COPD
  • Patients with CHD
  • Patients who have / had cancer that received chemotherapy or radiotherapy
More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01573676     History of Changes
Other Study ID Numbers: 0048-11-HYMC
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: April 2012

Keywords provided by Hillel Yaffe Medical Center:
bariatric surgery
sleep apnea
overweight

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