Assessing sleep apnea changes after same-day discharge bariatric surgery
Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea
This study is testing how same-day discharge after weight loss surgery affects sleep apnea in patients who might have it, to help determine safe discharge guidelines for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital Academic / other |
| Locations | 1 site (Elst) |
| Trial ID | NCT06452784 on ClinicalTrials.gov |
What this trial studies
This study evaluates the changes in the Apnea-Hypopnea Index (AHI) in patients undergoing same-day discharge bariatric surgery, particularly focusing on those with potentially untreated obstructive sleep apnea (OSA). A total of 60 patients will undergo home sleep apnea testing before surgery and on the first and third nights post-surgery to monitor AHI and sleep architecture. The goal is to establish appropriate discharge criteria for patients with OSA, as current guidelines are lacking. This research aims to provide insights into the safety and implications of same-day discharge for these patients.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing primary bariatric surgery who are eligible for same-day discharge and can use a smartphone.
Not a fit: Patients with diagnosed OSA who are currently receiving treatment or those undergoing revisional bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved discharge criteria for bariatric surgery patients with OSA, enhancing patient safety and outcomes.
How similar studies have performed: While there is limited research specifically on same-day discharge in bariatric surgery patients with OSA, similar studies have indicated that postoperative monitoring of AHI is crucial for patient safety.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergo primary bariatric surgery (Roux and y gastric bypass or sleeve gastrectomy) * Eligible for same-day discharge * In possession and able to use a smartphone Exclusion Criteria: * Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding) * Not eligible for same-day discharge * Diagnosed OSA with treatment (CPAP, oral appliances) * Professional drivers * Use of alpha blockers * Unable to speak or read the Dutch language * Not in possession or not able to use a smartphone
Where this trial is running
Elst
- Vitalys — Elst, Netherlands (Recruiting)
Study contacts
- Principal investigator: Eric Hazebroek, Professor — Vitalys part of Rijnstate
- 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.