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

R

Ramsay Générale de Santé

Status

Enrolling

Conditions

Bariatric Surgery Candidate
Obesity
Apnea, Obstructive

Treatments

Procedure: Bariatric surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04179188
2019-A00832-55

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Bariatric OSA Group
Description:
Bariatric surgery plannified intervention patient with obstructive sleep Apnéa
Treatment:
Procedure: Bariatric surgery
Bariatric without OSA Group
Description:
Bariatric surgery plannified intervention patient without obstructive sleep Apnéa
Treatment:
Procedure: Bariatric surgery

Trial contacts and locations

1

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Central trial contact

Jean-François OUDET; Marie Barba

Data sourced from clinicaltrials.gov

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