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

This study has been withdrawn prior to enrollment.
(not adequate resources)
Information provided by (Responsible Party):
Anthony Doufas, Stanford University Identifier:
First received: May 2, 2008
Last updated: October 17, 2016
Last verified: October 2016
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
Sleep Apnea, Obstructive
Procedure: Neurocognitive Testing
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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:

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 [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of preoperative neurocognitive impairment on the long term neurocognitive function after RYGB [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
  • The effect of preoperative neurocognitive impairment on the weight loss function after RYGB and how this relates to the presence of OSA [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

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 or drug abuse. Undergone a sleep study in the past

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Please refer to this study by its identifier: NCT00671983

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Anthony Doufas Stanford University
  More Information

Responsible Party: Anthony Doufas, Principle Investigator, Stanford University Identifier: NCT00671983     History of Changes
Other Study ID Numbers: SU-04282008-1124  11812 
Study First Received: May 2, 2008
Last Updated: October 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on October 21, 2016