NCT02523248

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5.8 years

First QC Date

August 6, 2015

Last Update Submit

March 29, 2022

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Polysomnography: group differences of changes in apnea-hypopnea index (AHI)

    measurements with inlab polysomnography

    6 months

Secondary Outcomes (3)

  • Questionnaire: group differences of changes in daytime sleepiness

    6 months

  • Questionnaire: group differences in changes of general health

    6 months

  • Group differences in changes of blood pressure

    6 months

Other Outcomes (5)

  • Polysomnography: group differences of changes in apnea-hypopnea index (AHI)

    4 years

  • Questionnaire: group differences of changes in daytime sleepiness

    4 years

  • Questionnaire: group differences in changes of general health

    4 years

  • +2 more other outcomes

Study Arms (2)

Tonsillectomy

ACTIVE COMPARATOR

Tonsillectomy with cold steel

Procedure: tonsillectomy

Uvulopalatopharyngoplasty

ACTIVE COMPARATOR

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

Procedure: Uvulopalatopharyngoplasty

Interventions

tonsillectomyPROCEDURE

Tonsillectomy with cold steel

Tonsillectomy
UvulopalatopharyngoplastyPROCEDURE

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

Also known as: UPPP
Uvulopalatopharyngoplasty

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe cardiovascular or neurological disease
  • Prefers strongly one surgical method
  • ASA IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orl dep, Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 36326742DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Bo Tideholm, MD, PhD

    Karolinska University Hospital, ORL dep

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 14, 2015

Study Start

January 1, 2016

Primary Completion

November 1, 2021

Study Completion

January 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

SE(1)