Comparing oxygen therapy effects on sleep apnea after bariatric surgery
Comparison of Apnea-Hypopnea Index, in Patients With Potentially Undiagnosed Obstructive Sleep Apnea, Treated With or Without Preventive Oxygen Therapy, During the First Night After Bariatric Surgery
NA · Rijnstate Hospital · NCT06432933
This study is testing whether giving oxygen therapy on the first night after bariatric surgery helps patients with possible sleep apnea breathe better while they sleep.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital (other) |
| Locations | 1 site (Elst) |
| Trial ID | NCT06432933 on ClinicalTrials.gov |
What this trial studies
This trial aims to determine the necessity of preventive oxygen therapy during the first postoperative night for patients undergoing bariatric surgery who may have undiagnosed obstructive sleep apnea (OSA). Participants will be randomized into two groups: one receiving standard care with oxygen therapy and the other receiving no oxygen therapy. The primary focus is to compare the Apnea-Hypopnea Index (AHI) between the two groups, while also assessing differences in sleep architecture. The study seeks to clarify the best perioperative management strategy for patients with potential OSA.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for primary bariatric surgery who do not have treated obstructive sleep apnea.
Not a fit: Patients with diagnosed obstructive sleep apnea who are already receiving treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize postoperative care for bariatric surgery patients, potentially reducing complications related to sleep apnea.
How similar studies have performed: Previous studies have shown that monitoring and oxygen therapy can be safe and cost-effective, but this specific approach in the bariatric population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergo primary bariatric surgery (RYGB or SG) * Speak and read the Dutch language Exclusion Criteria: * Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding) * Same-day discharge after bariatric surgery * Diagnosed OSA with treatment (CPAP, oral appliances) * Professional drivers * Use of alpha blockers * Unable to speak or read the Dutch language
Where this trial is running
Elst
- Vitalys — Elst, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Eric Hazebroek, Prof.dr. — Rijnstate Hospital
- Study coordinator: Claudia Berends, Msc
- Email: clberends@rijnstate.nl
- Phone: +31880055970
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.
Conditions: Obstructive Sleep Apnea, Obesity, Bariatric Surgery Candidate