Comparison Between UPPP and Tonsillectomy in Adult OSA

NCT ID: NCT02523248

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tonsillectomy

Tonsillectomy with cold steel

Group Type ACTIVE_COMPARATOR

tonsillectomy

Intervention Type PROCEDURE

Tonsillectomy with cold steel

Uvulopalatopharyngoplasty

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

Group Type ACTIVE_COMPARATOR

Uvulopalatopharyngoplasty

Intervention Type PROCEDURE

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

Interventions

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tonsillectomy

Tonsillectomy with cold steel

Intervention Type PROCEDURE

Uvulopalatopharyngoplasty

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

Intervention Type PROCEDURE

Other Intervention Names

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UPPP

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Danielle Friberg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Tideholm, MD, PhD

Role: STUDY_DIRECTOR

Karolinska University Hospital, ORL dep

Locations

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Orl dep, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 36326742 (View on PubMed)

Other Identifiers

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2015/755-31/2

Identifier Type: -

Identifier Source: org_study_id

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