Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort
NCT ID: NCT02012868
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
56 participants
OBSERVATIONAL
2012-03-31
2014-06-30
Brief Summary
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Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However these studies are biased by a huge number of drop outs. The drop out rate in the studies are around 60 percent.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that we can perform a study without a huge number of dropouts.
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Detailed Description
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OSA is associated with overweight. Studies have shown high prevalence (60-94%) of obstructive sleep apnea (OSA) among patients undergoing gastric bypass (bariatric) surgery.
Fifteen studies have investigated the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and the following weight loss. However, a huge number of dropouts biases these studies. The dropout rate in the studies are around 60 percent. No studies are from northern Europe.
The Investigators want to perform a study investigating the prevalence of OSA among over weighted patients undergoing bariatric surgery in Denmark.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that they can perform a study without a huge number of dropouts.
The investigators investigate patients by making sleep monitoring by embletta. During one night of sleep with this apparatus, the investigators will get information on number of wake-ups during sleep, the apnea-hypopnea index and saturation during sleep. All of this gives the investigators information whether the patient have OSA or not.
Patients will undergo sleep monitoring prior to surgery. The time interval from monitoring to day of surgery varies from 1 month to one day. the investigators repeat the sleep monitoring one year after date of surgery. Differences in primary endpoint and secondary endpoints is calculated.
Today all of the subjects have undergone surgery. From November 1.2013 the investigators invites all patients to sleep monitoring once again. The investigators were hot able to register this trial before this date because of the political situation in the US. This site was closed. The Investigators hope that the investigators still are able to register the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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bariatric surgery, obstructive sleep apnoea
bariatric surgery
bariatric surgery
Interventions
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bariatric surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* attending bariatric surgery
Exclusion Criteria
* micrognathia,
* acromegaly
* downs syndrome
18 Years
65 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Responsible Party
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Jeppe Gram
Doctor, PhD
Principal Investigators
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Philip Lage-Hansen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of endocrinology, Esbjerg
Locations
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Department of endocrinology, Southern west hospital
Esbjerg, , Denmark
Countries
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Other Identifiers
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S-20120004jln
Identifier Type: -
Identifier Source: org_study_id
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