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Assessment of pre- and postoperative Apnea-Hypopnea Index after Same-Day Discharge bariatric surgery in patients with potentially undiagnosed Obstructive Sleep Apnea

Recruiting
Conditions
slaap gerelateerde stoornissen in respiratie
Obstructive sleep apnea
sleep 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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
<p>Primary endpoint is Apnea-Hypopnea Index. </p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
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