Comparison Between UPPP and Tonsillectomy in Adult OSA

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: tonsillectomy; Procedure: Uvulopalatopharyngoplasty

• Registration Number: NCT02523248
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Study Start: 2016-01
• Primary Completion: 2021-11
• Study Completion: 2022-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tonsillectomy	tonsillectomy	Tonsillectomy with cold steel
Uvulopalatopharyngoplasty	Uvulopalatopharyngoplasty	Tonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle

Primary Outcome Measures

Name	Time	Method
Polysomnography: group differences of changes in apnea-hypopnea index (AHI)	6 months	measurements with inlab polysomnography

Secondary Outcome Measures

Name	Time	Method
Group differences in changes of blood pressure	6 months	Measurements of blood pressure the morning after inlab polysomnography
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

Trial Locations

Locations (1)

Orl dep, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden