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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01573676
First received: April 5, 2012
Last updated: April 6, 2012
Last verified: April 2012
  Purpose

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
Overweight
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA)

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Improvement in RDI after bariatric surgery [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Improvement will measured by polysonography


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bariatric surgery patients
Candidates for bariatric surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01573676     History of Changes
Other Study ID Numbers: 0048-11-HYMC
Study First Received: April 5, 2012
Last Updated: April 6, 2012
Health Authority: Israel: Ministry of Health

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 Disorders
Nervous System Diseases
Body Weight

ClinicalTrials.gov processed this record on August 20, 2014