RCT Between UPP and Controls in Adult OSA
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|ClinicalTrials.gov Identifier: NCT02522247|
Recruitment Status : Withdrawn (No patients have been enrolled, maybe in the future the study will start up again)
First Posted : August 13, 2015
Last Update Posted : July 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Procedure: UPP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls)|
|Estimated Primary Completion Date :||February 2022|
Active Comparator: Uvulopalatoplasty
Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle
surgery with cold steel in general anesthesia
Other Name: Uvulopalatoplasty
No Intervention: Controls
Only waiting 6 months
- Polysomnography: group differences in changes of apnea-hypopnea index (AHI) [ Time Frame: 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
- Questionnaire: group differences in changes of daytime sleepiness [ Time Frame: 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 [ Time Frame: 6 months ]using validated question
- Blood pressure: group differences in changes of blood pressure [ Time Frame: 6 months ]
- Polysomnography: changes of AHI between baseline and 4 years postoperatively [ Time Frame: 4 years ]The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
- Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively [ Time Frame: 4 years ]The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
- Questionnaire: changes of general health between baseline and after 4 years postoperatively [ Time Frame: 4 years ]The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
- Postoperative bleeding complications [ Time Frame: 6 months ]postop bleeding in milliliter
- Postoperative days at hospital [ Time Frame: 6 months ]report number of days at hospital postop
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522247
|Orl dep, Karolinska University Hospital|
|Stockholm, Sweden, 141 86|
|Study Director:||Bo Tideholm, Md, PhD||ORL-dep, Karolinska University Hospital|