The Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery

This study is not yet open for participant recruitment.

Verified by Stanford University, February 2009

First Received: May 2, 2008 Last Updated: February 17, 2009 History of Changes

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00671983

Purpose

Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive episodes of airway obstruction during sleep, which result in low oxygen level in the blood and bad sleep quality. Both of these effects are implicated in medical, neurological and cognitive disorders in subjects with OSA. The purpose of this study is to examine how OSA affects medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly obese patients.

Condition	Intervention	Phase
Obesity Sleep Apnea, Obstructive	Procedure: Neurocognitive Testing	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effect of Obstructive Sleep Apnea on Medical and Neurobehavioral Outcomes After Gastric Bypass Surgery - An Exploratory Investigation

Resource links provided by NLM:

MedlinePlus related topics: Obesity Sleep Apnea Surgery Weight Control

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

The effect of preoperative OSA on the long term neurocognitive function after Roux-en-Y gastric bypass (RYGB) surgery for weight loss in morbidly obese patients

Secondary Outcome Measures:

The effect of preoperative neurocognitive impairment on the long term neurocognitive function after RYGB
The effect of preoperative neurocognitive impairment on the weight loss function after RYGB and how this relates to the presence of OSA

Estimated Enrollment:	50
Study Start Date:	June 2009
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:-30 to 65 years of age

Scheduled for Laparoscopic roux-en-Y gastric bypass (RYGB) surgery
Presence or absence of OSA confirmed by polysomnography
Comprehension of spoken and written English

Exclusion Criteria:-Major psychiatric, neurological, or neuromuscular disorder

History of untreated thyroid disease
Known diabetes mellitus
History of stroke with or without apparent neurological deficits
Alcohol consumption which exceeds 2 drinks per day and /or drug abuse.
Undergone a sleep study in the past

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671983

Contacts

Contact: Anthony Doufas, MD, PhD

(650) 498-7699

agdoufas@stanford.edu

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Anthony Doufas

Stanford University

More Information

No publications provided

Responsible Party:	( Anthony Doufas, MD, PhD )
Study ID Numbers:	SU-04282008-1124, 11812
Study First Received:	May 2, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00671983 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Obesity
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Dyssomnias
Sleep Disorders
Overweight

Sleep Disorders, Intrinsic
Body Weight
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Nutrition Disorders
Overnutrition

Additional relevant MeSH terms:

Obesity
Sleep Apnea Syndromes
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders
Dyssomnias

Overweight
Sleep Disorders, Intrinsic
Body Weight
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Nutrition Disorders
Overnutrition

ClinicalTrials.gov processed this record on September 03, 2009