Effects of bariatric surgery on obese patients with and without sleep apnea
Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS
This study looks at how bariatric surgery affects obese patients, especially those with sleep apnea, to see if it improves their heart health and reduces surgery-related problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ramsay Générale de Santé Academic / other |
| Locations | 1 site (Lille, Haut de France) |
| Trial ID | NCT04179188 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of bariatric surgery on obese patients, particularly focusing on those with obstructive sleep apnea syndrome (OSAS). It aims to assess the improvement of cardiovascular risk factors and the incidence of post-surgical complications in patients with OSAS compared to those without. The study will include patients preparing for various types of bariatric surgery at the CELIOBE center. By analyzing outcomes, the research seeks to understand the specific challenges faced by OSAS patients undergoing this procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are preparing for bariatric surgery and have not previously undergone such procedures.
Not a fit: Patients who are already receiving CPAP treatment for sleep apnea or have had prior bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing bariatric surgery outcomes for patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown promising results regarding the benefits of bariatric surgery in improving obesity-related conditions, but the specific focus on OSAS patients is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille, Haut de France
- Hôpital privé La Louvière — Lille, Haut de France, France (Recruiting)
Study contacts
- Study coordinator: Jean-François OUDET
- Email: jf.oudet@ecten.eu
- Phone: 683346567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.