Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Not Applicable

Completed

• Conditions: Tonsillar Hypertrophy; Sleep Apnea, Obstructive

• Registration Number: NCT04314492
• Lead Sponsor: Turku University Hospital

Brief Summary

Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation

Detailed Description

The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.

Study Timeline

• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-09-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• age 16-64
• Planned tonsil surgery with informed concent
• Obstructive sleep apnea (AHI > 15)
• Tonsillar size of 3-4 on the Friedman scale

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index	6 months	Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.

Secondary Outcome Measures

Name	Time	Method
Total recovery of obstructive sleep apnea	6 months and 24 months and 60 months	Defined by apnea-hypopnea index \<5 post-operatively in polysomnography.
Snoring time	6 months and 24 months and 60 months	Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in
Quality of life measured by Glasgow Benefit Inventory	6 months and 24 month and 60 months	General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
Quality of life measured by Nordic tonsil surgery register questionnaire	6 months - up to 5 years	Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score.
Quality of life measured by Epworth sleepiness scale	6 months - up to 5 years	Questions regarding sleepiness. Score 0-24, lower is better.
Post-operative recovery	21 days	Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory.
Regrowth of tonsillar tissue	Pre-operative to 6 months	Measured by photography, Friedman scale (0-4, lower is smaller).
Apnea-index	6 months and 24 months and 60 months	Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography.

Trial Locations

Locations (2)

Satasairaala; 🇫🇮 Pori, Satakunta, Finland

Turku University Hospital; 🇫🇮 Turku, Varsinais-Suomi, Finland