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Completed

NCT Number: NCT04314492

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

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Key information

Conditions

Tonsillar Hypertrophy Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Satasairaala, Pori, Satakunta, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tonsillectomy

Procedure

Intracapsular removal of tonsillar tissue (>90%) with coblation

Primary outcomes

  1. Apnea-hypopnea index

    Time frame: 6 months

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

Secondary outcomes

  1. Quality of life measured by Glasgow Benefit Inventory

    Time frame: 6 months and 24 month and 60 months

    General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.

  2. Quality of life measured by Nordic tonsil surgery register questionnaire

    Time frame: 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.

  3. Quality of life measured by Epworth sleepiness scale

    Time frame: 6 months - up to 5 years

    Questions regarding sleepiness. Score 0-24, lower is better.

  4. Post-operative recovery

    Time frame: 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.

  5. Total recovery of obstructive sleep apnea

    Time frame: 6 months and 24 months and 60 months

    Defined by apnea-hypopnea index <5 post-operatively in polysomnography.

  6. Regrowth of tonsillar tissue

    Time frame: Pre-operative to 6 months

    Measured by photography, Friedman scale (0-4, lower is smaller).

  7. Apnea-index

    Time frame: 6 months and 24 months and 60 months

    Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography.

  8. Snoring time

    Time frame: 6 months and 24 months and 60 months

    Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in

Other outcomes

  1. Apnea-hypopnea index

    Time frame: 24 months

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

  2. Apnea-hypopnea index

    Time frame: 60 months

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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2020
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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