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

Primary Purpose

Obstructive Sleep Apnea, Tonsillar Hypertrophy, Sleep Apnea Syndromes

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Polysomnography
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring tonsillectomy, obstructive sleep apnea, tonsil surgery

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polysomnography for all participants of the study

Arm Description

Polysomnography device is used to measure certain variables overnight when a participant is sleeping

Outcomes

Primary Outcome Measures

Apnea-hypopnea index
Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.

Secondary Outcome Measures

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

Full Information

First Posted
September 10, 2021
Last Updated
November 1, 2022
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05049369
Brief Title
Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Official Title
Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Tonsillar Hypertrophy, Sleep Apnea Syndromes
Keywords
tonsillectomy, obstructive sleep apnea, tonsil surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polysomnography for all participants of the study
Arm Type
Experimental
Arm Description
Polysomnography device is used to measure certain variables overnight when a participant is sleeping
Intervention Type
Device
Intervention Name(s)
Polysomnography
Intervention Description
Polysomnography is performed one time overnight
Primary Outcome Measure Information:
Title
Apnea-hypopnea index
Description
Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.
Time Frame
3-17 years
Secondary Outcome Measure Information:
Title
Quality of life measured by Glasgow Benefit Inventory (GBI)
Description
General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
Time Frame
3-17 years
Title
Quality of life measured by Epworth sleepiness scale (ESS)
Description
Questions regarding sleepiness. Score 0-24, lower is better.
Time Frame
3-17 years
Title
Apnea-index (AI)
Description
Post-operative apnea index reduction compared to preoperative values in polysomnography.
Time Frame
3-17 years
Title
Snoring time
Description
Post-operative reduction of snoring time compared to preoperative values in polysomnography
Time Frame
3-17 years
Title
Oxygen Desaturation Index (ODI)
Description
Post-operative reduction of oxygen desaturation index compared to preoperative values in polysomnography
Time Frame
3-17 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaakko M Piitulainen, MD,PhD
Organizational Affiliation
Department of Otorhinolaryngology, Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
Southwest Finland
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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