Clinical trial NCT02012868: Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort
Official title: Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnoea (OSA)
Keywords: obstructive sleep apnoea
weight loss
bariatric surgery
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients attending bariatric surgery

Brief summary: Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery.

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.

Detailed description: Obstructive sleep apnea (OSA) is a clinical syndrome characterized by occlusion of upper airways during sleep. The occlusions results in shortly hypoxia, which awakes the patient. When the patient awakes, activity in the pharyngeal muscles results in opening of the upper airway again.

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.

Eligibility criteria: Inclusion Criteria:

* BMI \> 35
* attending bariatric surgery

Exclusion Criteria:

* retrognathia
* micrognathia,
* acromegaly
* downs syndrome

Primary outcomes:
measure: AHI
timeFrame: Change from baseline in AHI at one year
Secondary outcomes:
measure: weight
timeFrame: Change from baseline in weight at one year
measure: Circumference of neck
timeFrame: Change from baseline in Circumference at neck at one year
measure: mean saturation during sleep
timeFrame: Change from baseline in mean saturation during sleep at one year
Other outcomes:
measure: ESS score
timeFrame: Change from baseline in ESS score at one year
Locations:
city: Esbjerg
country: Denmark
facility: Department of endocrinology, Southern west hospital
Study officials:
affiliation: Department of endocrinology, Esbjerg
name: Philip Lage-Hansen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: