Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Sleep Apnea, Obstructive Clinical Trial

Official title:

Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314492
• Other study ID #: T62/2020
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 2029

Study information

• Verified date: November 2023
• Source: Turku University Hospital
• Contact: Henrik M. Sjöblom, M.D.
• Phone: 023130000
• Email: hmsjob[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2029
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypertrophy
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Tonsillar Hypertrophy

Intervention

Procedure:
• Tonsillectomy
Intracapsular removal of tonsillar tissue (>90%) with coblation

Locations

Country	Name	City	State
Finland	Satasairaala	Pori	Satakunta
Finland	Turku University Hospital	Turku	Varsinais-Suomi

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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