Assessment of pre- and postoperative Apnea-Hypopnea Index after Same-Day Discharge bariatric surgery in patients with potentially undiagnosed Obstructive Sleep Apnea
- Conditions
- slaap gerelateerde stoornissen in respiratieObstructive sleep apneasleep disordered breathing
- Registration Number
- NL-OMON56650
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
- Rijnstate criteria for SDD bariatric surgery:
- Age >=18 years
- During the first postoperative night an adult person (=caregiver)
must be
present at the home or residence of the patient, to seek medical attention
if needed
- Both patient and caregiver must speak and read the Dutch language
- During the first postoperative night the patients must reside within
a 60- minute radius of Rijnstate hospital (Arnhem)
- Undergo primary bariatric surgery (RYGB or SG)
- In possession and able to use a smartphone
- Rijnstate exclusion criteria for SDD bariatric surgery
- Not living in the Netherlands
- Patients from psychiatric wards, inmates of prisons and other state
institutions
- Insulin dependent diabetes
- Patients with active implants such as ICD and pacemaker
- Patients using a beta-blocker
- Patients diagnosed with OSA but without treatment
- Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric
banding)
- 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is Apnea-Hypopnea Index. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary and tertiary endpoints are 30 days complications rate, and parameters<br /><br>for sleep architecture and sleep related breathing (in minutes and percentages;<br /><br>oxygenation desaturation index (ODI), Rapid eye movement (REM) sleep, deep<br /><br>sleep, light sleep, wake time, REM AHI , Respiratory disturbance index (RDI),<br /><br>Total sleep time, saturation <90%, mean saturation, mean saturation during<br /><br>desaturations, number of desaturations). </p><br>