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

NCT02012868 | Completed

• 1 other identifier: S-20120004jln
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnoea (OSA)

Keywords

obstructive sleep apnoea; weight loss; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• AHI

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

  Change from baseline in AHI at one year

Secondary Outcomes (3)

• weight

  Change from baseline in weight at one year

• Circumference of neck

  Change from baseline in Circumference at neck at one year

• mean saturation during sleep

  Change from baseline in mean saturation during sleep at one year

Other Outcomes (1)

• ESS score

  Change from baseline in ESS score at one year

Study Arms (1)

bariatric surgery, obstructive sleep apnoea

bariatric surgery

Procedure: bariatric surgery

Interventions

bariatric surgery PROCEDURE

Also known as: gastric bypass

bariatric surgery, obstructive sleep apnoea

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients attending bariatric surgery

You may qualify if:

• BMI \> 35
• attending bariatric surgery

You may not qualify if:

• retrognathia
• micrognathia,
• acromegaly
• downs syndrome

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Department of endocrinology, Southern west hospital

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Weight Loss

Interventions

Bariatric Surgery; Gastric Bypass

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Gastroenterostomy; Anastomosis, Surgical; Digestive System Surgical Procedures

Study Officials

• Philip Lage-Hansen, Doctor

  Department of endocrinology, Esbjerg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, PhD

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 16, 2013
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

DK (1)