Back to resultsThe Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery
Primary Purpose
Obesity, Sleep Apnea, Obstructive
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neurocognitive Testing
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00671983
Brief Title
The Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery
Official Title
The Effect of Obstructive Sleep Apnea on Medical and Neurobehavioral Outcomes After Gastric Bypass Surgery - An Exploratory Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
not adequate resources
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Neurocognitive Testing
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The effect of preoperative neurocognitive impairment on the long term neurocognitive function after RYGB
Time Frame
1 year after surgery
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Doufas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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The Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery
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