NCT00671983WithdrawnPhase 1
The Effect of Obstructive Sleep Apnea on Medical and Neurobehavioral Outcomes After Gastric Bypass Surgery - An Exploratory Investigation
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Anthony Doufas
Principle Investigator
Stanford University
Study Sites (1)
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