Obstructive Sleep Apnea
Conditions
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.
Interventions
PROCEDUREUPP
surgery with cold steel in general anesthesia
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Severe cardiovascular or neurological disease * ASA IV * Not interested in surgical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography: changes of AHI between baseline and 4 years postoperatively | 4 years | The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients. |
| Postoperative days at hospital | 6 months | report number of days at hospital postop |
| Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively | 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 | 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 | 6 months | postop bleeding in milliliter |
Countries
Sweden
Outcome results
None listed