Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome (COLOSS)

Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS

It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Bariatric Surgery Candidate; Apnea, Obstructive
• Intervention / Treatment: Procedure: Bariatric surgery

Detailed Description

It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors.

Bariatric surgery is now the most effective intervention for the long-term treatment of obesity and its complications. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. The progressive loss of weight contributes to the regression of the symptoms related to OSA. Observational studies have shown that bariatric surgery can rapidly improve glycemic control and cardiovascular risk factors with a significantly higher remission rate of hypertension and dyslipidemias than in the non-surgical group. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jean-François OUDET; Phone Number: 683346567 683346567; Email: jf.oudet@ecten.eu

Study Locations

• France
  • Haut De France
    • Lille, Haut De France, France, 59800
      • Recruiting
      • Hôpital Privé La Louvière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient in preparation for bariatric surgery in the center CELIOBE

Description

Inclusion Criteria:

• Patient, male or female, aged over 18
• Patient in preparation for bariatric surgery (ring, Sleeve gastrectomy or Bypass) in the center CELIOBE.
• Patient affiliated with social security or beneficiary of such a scheme
• Patient having signed the free and informed consent

Exclusion Criteria:

• Patient who has already had bariatric surgery (ring, sleeve gastrectomy or bypass).
• Patient already receiving CPAP treatment for sleep apnea syndrome.
• Patients with pathology indicating the use of CPAP in self-guided mode (heart failure with altered ejection fraction) for patients diagnosed with OSAS
• Patient likely, in the opinion of the investigator, not to be cooperative or respectful of the obligations inherent to participation in the study
• Patient suffering from mental pathology does not make possible the collection of a consent.
• Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, lactating or parturient woman
• Patient hospitalized without consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bariatric OSA Group; Bariatric surgery plannified intervention patient with obstructive sleep Apnéa	Procedure: Bariatric surgery; Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)
Bariatric without OSA Group; Bariatric surgery plannified intervention patient without obstructive sleep Apnéa	Procedure: Bariatric surgery; Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertension	The primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.	1 year

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Dr CODRON

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Anticipated): November 30, 2025
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: obesity; Obstructive Sleep Apnea; Bariatric Surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2019-A00832-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No