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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02523248
Other study ID # 2015/755-31/2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date January 2022

Study information

Verified date March 2022
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date January 2022
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
tonsillectomy
Tonsillectomy with cold steel
Uvulopalatopharyngoplasty
Tonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle

Locations

Country Name City State
Sweden Orl dep, Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Polysomnography: group differences of changes in apnea-hypopnea index (AHI) measurements with inlab polysomnography 4 years
Other Questionnaire: group differences of changes in daytime sleepiness A validated questionnaire: Epworth sleepiness scale 4 years
Other Questionnaire: group differences in changes of general health A validated question of self-reported health 4 years
Other Questionnaire of pharyngeal side-effects pre-and postoperatively Questionnaire with 10 questions of pharyngeal disturbances administrated before and 6 months after surgery 6 months
Other Postoperative bleeding complications Patient charts how many days patients stayed at hospitals postoperatively, reoperations and medications 6 months
Primary Polysomnography: group differences of changes in apnea-hypopnea index (AHI) measurements with inlab polysomnography 6 months
Secondary Questionnaire: group differences of changes in daytime sleepiness A validated questionnaire: Epworth sleepiness scale 6 months
Secondary Questionnaire: group differences in changes of general health A validated question of self-reported health 6 months
Secondary Group differences in changes of blood pressure Measurements of blood pressure the morning after inlab polysomnography 6 months
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