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Completed

NCT Number: NCT02012868

Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort

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.

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Key information

Conditions

Obstructive Sleep Apnoea (OSA) Apnea Body Weight Body Weight Changes Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of endocrinology, Southern west hospital

Esbjerg, 6700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI > 35
  • attending bariatric surgery

Exclusion criteria

  • retrognathia
  • micrognathia,
  • acromegaly
  • downs syndrome

Treatment and study plan

bariatric surgery

Procedure

Other names: gastric bypass

Primary outcomes

  1. AHI

    Time frame: Change from baseline in AHI at one year

    Obstructive sleep apnoea is defined by the apnoea/hypopnoea index (AHI). This can be accessed by embletta monitoring during sleep.

Secondary outcomes

  1. weight

    Time frame: Change from baseline in weight at one year

    No need.

  2. Circumference of neck

    Time frame: Change from baseline in Circumference at neck at one year

    Circumference of the neck measured in inches.

  3. mean saturation during sleep

    Time frame: Change from baseline in mean saturation during sleep at one year

    saturation during sleep is measured by a pulsoxymetry.

Other outcomes

  1. ESS score

    Time frame: Change from baseline in ESS score at one year

    ESS is a questionnaire that gives an impression on quality of sleep. High score indicate poor quality of sleep. Low score indicate high quality of sleep.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 16, 2013
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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