Comparison Between UPPP and Tonsillectomy in Adult OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Randomized Control Study Between Uvulopalatopharyngoplasty and Tonsillectomy in Adult Sleep Apnea Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02523248
• Other study ID #: 2015/755-31/2
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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