Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive; Tonsillar Hypertrophy
• Intervention / Treatment: Procedure: Tonsillectomy

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrik M. Sjöblom, M.D.; Phone Number: +358 023130000; Email: hmsjob@utu.fi
• Study Contact Backup: Name: Jaakko Piitulainen, M.D., Ph.D.; Phone Number: +358 023138088; Email: jaakko.piitulainen@tyks.fi

Study Locations

• Finland
  • Satakunta
    • Pori, Satakunta, Finland, 28500
      • Recruiting
      • Satasairaala
      • Contact: Emilia Mikola, M.D:; Phone Number: 02 627 71
      • Contact: Lauriina Lustig-Tammi, M.D:; Phone Number: 02 627 71
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20521
      • Recruiting
      • Turku University Hospital
      • Contact: Jaakko Piitulainen, MD, PhD; Phone Number: 02 313 8088; Email: jaakko.piitulainen@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracapsular tonsillectomy with coblation; (Total) Intracapsular tonsillectomy (ICTE) with coblation	Procedure: Tonsillectomy; Intracapsular removal of tonsillar tissue (>90%) with coblation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index	Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quality of life measured by Epworth sleepiness scale	Questions regarding sleepiness. Score 0-24, lower is better.	6 months - up to 5 years
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
Regrowth of tonsillar tissue	Measured by photography, Friedman scale (0-4, lower is smaller).	Pre-operative to 6 months
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
Total recovery of obstructive sleep apnea	Defined by apnea-hypopnea index <5 post-operatively in polysomnography.	6 months and 24 months and 60 months
Apnea-index	Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography.	6 months and 24 months and 60 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index	Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.	24 months
Apnea-hypopnea index	Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.	60 months

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Study Director: Jussi Jero, Professor, University of Turku; Principal Investigator: Jaakko Piitulainen, M.D., Ph.D., Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; tonsillectomy; tonsil surgery; intracapsular; coblation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pathological Conditions, Anatomical; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Hypertrophy
• Other Study ID Numbers: T62/2020

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