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

Obesity Clinical Trial

— COLOSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179188
• Other study ID #: 2019-A00832-55
• Status: Recruiting
• Start date: October 9, 2019
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2019
• Source: Ramsay Générale de Santé
• Contact: Jean-François OUDET
• Phone: 683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 31, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Apnea, Obstructive
• Bariatric Surgery Candidate
• Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Bariatric surgery
Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)

Locations

Country	Name	City	State
France	Hôpital privé La Louvière	Lille	Haut De France

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Dr CODRON

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertension	The primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.	1 year