Obstructive Sleep Apnea
Conditions
Brief summary
The aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.
Detailed description
Patients are after baseline PSG 1 included and randomized to either UPPP or TE. They are stratified according to tonsil size, those with size 2 in one group and those with 3-4 in another. They all undergo surgery within two months and thereafter PSG 2 after 6 months and PSG after 4 years. At PSG they fill in questionnaires and measurements of blood pressure.
Interventions
PROCEDUREtonsillectomy
Tonsillectomy with cold steel
PROCEDUREUvulopalatopharyngoplasty
Tonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle
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 more than 15 * Friedmans stage I and II * Tonsil size 2, 3 and 4 * BMI below 34 * Failed use of CPAP and dental device
Exclusion criteria
* Severe cardiovascular or neurological disease * Prefers strongly one surgical method * ASA IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography: group differences of changes in apnea-hypopnea index (AHI) | 6 months | measurements with inlab polysomnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire: group differences of changes in daytime sleepiness | 6 months | A validated questionnaire: Epworth sleepiness scale |
| Questionnaire: group differences in changes of general health | 6 months | A validated question of self-reported health |
| Group differences in changes of blood pressure | 6 months | Measurements of blood pressure the morning after inlab polysomnography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography: group differences of changes in apnea-hypopnea index (AHI) | 4 years | measurements with inlab polysomnography |
| Postoperative bleeding complications | 6 months | Patient charts how many days patients stayed at hospitals postoperatively, reoperations and medications |
| Questionnaire: group differences of changes in daytime sleepiness | 4 years | A validated questionnaire: Epworth sleepiness scale |
| Questionnaire: group differences in changes of general health | 4 years | A validated question of self-reported health |
| Questionnaire of pharyngeal side-effects pre-and postoperatively | 6 months | Questionnaire with 10 questions of pharyngeal disturbances administrated before and 6 months after surgery |
Countries
Sweden
Outcome results
None listed