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Clinical Trials/NCT00671983
NCT00671983
Withdrawn
Phase 1

The Effect of Obstructive Sleep Apnea on Medical and Neurobehavioral Outcomes After Gastric Bypass Surgery - An Exploratory Investigation

Stanford University1 site in 1 countryMarch 2010
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ConditionsObesitySleep Apnea, Obstructive

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Obesity
Sponsor
Stanford University
Locations
1
Primary Endpoint
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
Status
Withdrawn
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
July 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anthony Doufas

Principle Investigator

Stanford University

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

Outcomes

Primary Outcomes

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 Outcomes

  • The effect of preoperative neurocognitive impairment on the long term neurocognitive function after RYGB(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(1 year after surgery)

Study Sites (1)

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