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NCT06376383 | Not yet recruiting | Obstructive Sleep Apnea

Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea
Sponsor:

University of Aarhus

Brief Summary:

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.

Condition or disease

Obstructive Sleep Apnea

Tonsillar Hypertrophy

Intervention/treatment

Tonsillectomy

Tonsillotomy

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 464 participants
Masking : Double
Primary Purpose : Treatment
Official Title : Tonsillectomy Versus Tonsillotomy in Adults With Obstructive Sleep Apnea; a Randomized Controlled Trial Comparing Postoperative Morbidity
Actual Study Start Date : January 2025
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : September 2027
Arm Intervention/treatment

Active Comparator: Tonsillectomy

Patients undergo standard removal of subcapsular removal of palatine tonsils

Procedure: Tonsillectomy

Experimental: Tonsillotomy

Patients undergo intracapsular reduction of palatine tonsils

Procedure: Tonsillotomy
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

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Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

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