Comparison Between UPPP and Tonsillectomy in Adult OSA

March 29, 2022 updated by: Danielle Friberg, Karolinska University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Orl dep, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tonsillectomy
Tonsillectomy with cold steel
Procedure: tonsillectomy
Tonsillectomy with cold steel
Active Comparator: Uvulopalatopharyngoplasty
Tonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle
Procedure: Uvulopalatopharyngoplasty
Tonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle
Other Names:
  • UPPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
Time Frame: 6 months
measurements with inlab polysomnography
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire: group differences of changes in daytime sleepiness
Time Frame: 6 months
A validated questionnaire: Epworth sleepiness scale
6 months
Questionnaire: group differences in changes of general health
Time Frame: 6 months
A validated question of self-reported health
6 months
Group differences in changes of blood pressure
Time Frame: 6 months
Measurements of blood pressure the morning after inlab polysomnography
6 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Study Director: Bo Tideholm, MD, PhD, Karolinska University Hospital, ORL dep

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/755-31/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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