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Comparison Between UPPP and Tonsillectomy in Adult OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
tonsillectomy
Uvulopalatopharyngoplasty
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orl dep, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tonsillectomy

Uvulopalatopharyngoplasty

Arm Description

Tonsillectomy with cold steel

Tonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle

Outcomes

Primary Outcome Measures

Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
measurements with inlab polysomnography

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2015
Last Updated
March 29, 2022
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02523248
Brief Title
Comparison Between UPPP and Tonsillectomy in Adult OSA
Official Title
Randomized Control Study Between Uvulopalatopharyngoplasty and Tonsillectomy in Adult Sleep Apnea Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Because of Covid 19 pandemic situation delay in recruiting patients
Study Start Date
January 2016 (Actual)
Primary Completion Date
November 2021 (Actual)
Study Completion Date
January 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tonsillectomy
Arm Type
Active Comparator
Arm Description
Tonsillectomy with cold steel
Arm Title
Uvulopalatopharyngoplasty
Arm Type
Active Comparator
Arm Description
Tonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle
Intervention Type
Procedure
Intervention Name(s)
tonsillectomy
Intervention Description
Tonsillectomy with cold steel
Intervention Type
Procedure
Intervention Name(s)
Uvulopalatopharyngoplasty
Other Intervention Name(s)
UPPP
Intervention Description
Tonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle
Primary Outcome Measure Information:
Title
Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
Description
measurements with inlab polysomnography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Questionnaire: group differences of changes in daytime sleepiness
Description
A validated questionnaire: Epworth sleepiness scale
Time Frame
6 months
Title
Questionnaire: group differences in changes of general health
Description
A validated question of self-reported health
Time Frame
6 months
Title
Group differences in changes of blood pressure
Description
Measurements of blood pressure the morning after inlab polysomnography
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
Description
measurements with inlab polysomnography
Time Frame
4 years
Title
Questionnaire: group differences of changes in daytime sleepiness
Description
A validated questionnaire: Epworth sleepiness scale
Time Frame
4 years
Title
Questionnaire: group differences in changes of general health
Description
A validated question of self-reported health
Time Frame
4 years
Title
Questionnaire of pharyngeal side-effects pre-and postoperatively
Description
Questionnaire with 10 questions of pharyngeal disturbances administrated before and 6 months after surgery
Time Frame
6 months
Title
Postoperative bleeding complications
Description
Patient charts how many days patients stayed at hospitals postoperatively, reoperations and medications
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Tideholm, MD, PhD
Organizational Affiliation
Karolinska University Hospital, ORL dep
Official's Role
Study Director
Facility Information:
Facility Name
Orl dep, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
36326742
Citation
Sundman J, Nerfeldt P, Fehrm J, Bring J, Browaldh N, Friberg D. Effectiveness of Tonsillectomy vs Modified Uvulopalatopharyngoplasty in Patients With Tonsillar Hypertrophy and Obstructive Sleep Apnea: The TEAMUP Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Dec 1;148(12):1173-1181. doi: 10.1001/jamaoto.2022.3432.
Results Reference
derived

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Comparison Between UPPP and Tonsillectomy in Adult OSA

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