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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671983
First Posted: May 6, 2008
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthony Doufas, Stanford University
  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 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Anthony Doufas, 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 ]

Secondary Outcome Measures:
  • The effect of preoperative neurocognitive impairment on the long term neurocognitive function after RYGB [ Time Frame: 1 year after surgery ]
  • 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 ]

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671983


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

Responsible Party: Anthony Doufas, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00671983     History of Changes
Other Study ID Numbers: SU-04282008-1124
11812
First Submitted: May 2, 2008
First Posted: May 6, 2008
Last Update Posted: October 18, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
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