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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00671983
First received: May 2, 2008
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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:

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 [ Time Frame: 1 year after sugery ] [ 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 ]

Estimated Enrollment: 50
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

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

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, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00671983     History of Changes
Other Study ID Numbers: SU-04282008-1124, 11812
Study First Received: May 2, 2008
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013