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

Phase 1

Withdrawn

• Conditions: Obesity; Sleep Apnea, Obstructive

• Registration Number: NCT00671983
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-06
• Study Start: 2010-03
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	1 year after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States