Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

December 22, 2023 updated by: Turku University Hospital
Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.

Study Type

Interventional

Enrollment (Actual)

17

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

  • Finland
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20521
        • Turku 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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age at least 16 during tonsillectomy
  • preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) > 14
  • tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)
  • in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate

Exclusion Criteria:

  • AHI < 14
  • in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
  • other, evaluated by investigator

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polysomnography for all participants of the study
Polysomnography device is used to measure certain variables overnight when a participant is sleeping
Device: Polysomnography
Polysomnography is performed one time overnight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-hypopnea index
Time Frame: 3-17 years
Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.
3-17 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measured by Glasgow Benefit Inventory (GBI)
Time Frame: 3-17 years
General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
3-17 years
Quality of life measured by Epworth sleepiness scale (ESS)
Time Frame: 3-17 years
Questions regarding sleepiness. Score 0-24, lower is better.
3-17 years
Apnea-index (AI)
Time Frame: 3-17 years
Post-operative apnea index reduction compared to preoperative values in polysomnography.
3-17 years
Snoring time
Time Frame: 3-17 years
Post-operative reduction of snoring time compared to preoperative values in polysomnography
3-17 years
Oxygen Desaturation Index (ODI)
Time Frame: 3-17 years
Post-operative reduction of oxygen desaturation index compared to preoperative values in polysomnography
3-17 years

Collaborators and Investigators

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

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Jaakko M Piitulainen, MD,PhD, Department of Otorhinolaryngology, Turku University Hospital

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 25, 2022

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

December 4, 2022

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T205/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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