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NCT01573676 Clinical Trial

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

Overweight Clinical Trial

— OSA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01573676
Other study ID # 0048-11-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 5, 2012
Last updated April 6, 2012
Start date May 2012
Est. completion date December 2013

Study information
Verified date April 2012
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 2013
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in RDI after bariatric surgery Improvement will measured by polysonography Six months No
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