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NCT Number: NCT06376383

Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Tonsil size 2, 3, or 4 (Friedman tonsil scale)
  • Confirmed OSA with sleep analysis not older than a year either CRM or PSG
  • ASA 1 or 2
  • BMI < 35 kg/m2

Exclusion criteria

Children age < 18 years

  • Previous pharyngeal surgery such as previous tonsillotomy, tonsillectomy or palatal surgery
  • Epileptic disease or severe neurological comorbidity.
  • ASA 3, or 4.
  • Central sleep apnea
  • Previous thrombotic disease.
  • Currently treated with sleep medications
  • No collapse of oropharyngeal lateral wall during DISE
  • Dropout of study, lack of sleep analysis or lack of postoperative DISE.

Treatment and study plan

Tonsillectomy

Procedure

Standard tonsillectomy

Other names: TE

Tonsillotomy

Procedure

Tonsillotomy

Other names: TT

Primary outcomes

  1. Postoperative hemorrhage

    Time frame: 14 days

    Postoperative hemorrhage event - readmission to the hospital

  2. Postoperative pain

    Time frame: 30 days

    Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.

  3. Recovery time - Sick leave

    Time frame: 30 days

    Sick-leave in days, measured when the patient is at work or back at school, day 0 = surgery day and outcome day is last day of sick-leave

  4. Morbidity

    Time frame: 30 days

    Re-admission at the hospital. Event is registered as null if no re-admission occurs and 1 or 2 etc. if re-admission occurs within first 30 days after surgery

Secondary outcomes

  1. AHI

    Time frame: 180 days

    Apnea Hypopnea Index before and after surgery. Increase in AHI means worsening in apnea hypopnea index. AHI is measured by performing at home type 3 sleep registration

  2. DISE - VOTE

    Time frame: 180 days

    Velum Oropharyngeal Tongue base Epiglottis (VOTE) evaluation. 0 = no collaps

    • = partial collaps
    • = complete collaps

Study contacts

Contact information is provided by the study sponsor or research team.

Kasra Zainali-Gill, Ph.D

CONTACT

[email protected]

+4578439744

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Tonsillectomy Versus Tonsillotomy in Adults With Obstructive Sleep Apnea; a Randomized Controlled Trial Comparing Postoperative Morbidity

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 19, 2024
Registry last updated
Apr 19, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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