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

Recruiting

• Conditions: Obesity; Bariatric Surgery Candidate; Apnea, Obstructive
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT04179188
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

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.

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 Timeline

• Study Start: 2019-10-09
• Status Verified: 2019-11
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-27
• Primary Completion: 2025-11-30
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric OSA Group	Bariatric surgery	Bariatric surgery plannified intervention patient with obstructive sleep Apnéa
Bariatric without OSA Group	Bariatric surgery	Bariatric surgery plannified intervention patient without obstructive sleep Apnéa

Primary Outcome Measures

Name	Time	Method
Hypertension	1 year	The primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.

Trial Locations

Locations (1)

Hôpital privé La Louvière; 🇫🇷 Lille, Haut De France, France