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No patients have been enrolled, and will not. The study was never started
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To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uvulopalatoplasty | Active Comparator | Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle |
|
| Controls | No Intervention | Only waiting 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UPP | Procedure | surgery with cold steel in general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography: group differences in changes of apnea-hypopnea index (AHI) | compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire: group differences in changes of daytime sleepiness | using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups | 6 months |
| Questionnaire: group differences in changes of general health |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography: changes of AHI between baseline and 4 years postoperatively | The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients. | 4 years |
| Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Tideholm, Md, PhD | ORL-dep, Karolinska University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orl dep, Karolinska University Hospital | Stockholm | 141 86 | Sweden |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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using validated question |
| 6 months |
| Blood pressure: group differences in changes of blood pressure | 6 months |
The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients. |
| 4 years |
| Questionnaire: changes of general health between baseline and after 4 years postoperatively | The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients. | 4 years |
| Postoperative bleeding complications | postop bleeding in milliliter | 6 months |
| Postoperative days at hospital | report number of days at hospital postop | 6 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |