Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
1 other identifier
interventional
25
1 country
2
Brief Summary
Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
2 active sites
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
March 13, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedApril 25, 2025
April 1, 2025
4.4 years
March 13, 2020
April 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea-hypopnea index
Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.
6 months
Secondary Outcomes (8)
Quality of life measured by Glasgow Benefit Inventory
6 months and 24 month and 60 months
Quality of life measured by Nordic tonsil surgery register questionnaire
6 months - up to 5 years
Quality of life measured by Epworth sleepiness scale
6 months - up to 5 years
Post-operative recovery
21 days
Total recovery of obstructive sleep apnea
6 months and 24 months and 60 months
- +3 more secondary outcomes
Other Outcomes (2)
Apnea-hypopnea index
24 months
Apnea-hypopnea index
60 months
Study Arms (1)
Intracapsular tonsillectomy with coblation
EXPERIMENTAL(Total) Intracapsular tonsillectomy (ICTE) with coblation
Interventions
Intracapsular removal of tonsillar tissue (\>90%) with coblation
Eligibility Criteria
You may qualify if:
- age 16-64
- Planned tonsil surgery with informed concent
- Obstructive sleep apnea (AHI \> 15)
- Tonsillar size of 3-4 on the Friedman scale
You may not qualify if:
- BMI \> 35 (Based on finnish Käypä Hoito -recommendations)
- Central sleep apnea
- Weight loss of more than 10% within the study period
- Untreated obstruction of nasal breathing
- Treated peritonsillar abscess \<1 month before enrollment
- Active tonsillar infection
- Previous tonsillar surgery (excluding incision of abscess)
- Malignancy
- High use of analgesics \>1 DDD daily during last 4 weeks
- Untreated reflux
- Anticoagulative medication
- Any condition of hemophilia
- Pregnancy, lactation
- Other, evaluated by treating physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Satasairaala
Pori, Satakunta, 28500, Finland
Turku University Hospital
Turku, Southwest Finland, 20521, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jussi Jero, Professor
University of Turku
- PRINCIPAL INVESTIGATOR
Jaakko Piitulainen, M.D., Ph.D.
Turku University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant, Doctor of Medical Science
Study Record Dates
First Submitted
March 13, 2020
First Posted
March 19, 2020
Study Start
September 1, 2020
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share