RCT Between UPP and Controls in Adult OSA
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT02522247
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.
- Detailed Description
Two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (PSG1) and a PSG2 6 months after surgery .
The control group perform PSG 1 and are then waiting 6 months, thereafter undergo PSG2, then surgery and PSG3 6 months after surgery. All patients are followed for four years with PSG. Patients fill in questionnaires at PSG sessions, and blood pressure control the morning after.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- AHI of 15 or more
- Friedmans stage I+II
- Tonsil size 0-1
- BMI<34
- ESS värde >7
- Failed treatment with CPAP and mandibular device
- Severe cardiovascular or neurological disease
- ASA IV
- Not interested in surgical treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Polysomnography: group differences in changes of apnea-hypopnea index (AHI) 6 months compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up
- Secondary Outcome Measures
Name Time Method Questionnaire: group differences in changes of daytime sleepiness 6 months using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups
Questionnaire: group differences in changes of general health 6 months using validated question
Blood pressure: group differences in changes of blood pressure 6 months
Trial Locations
- Locations (1)
Orl dep, Karolinska University Hospital
🇸🇪Stockholm, Sweden
Orl dep, Karolinska University Hospital🇸🇪Stockholm, Sweden