Menu
Not yet recruiting NCT06376383

Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

No phase Interventional Obstructive Sleep Apnea Tonsillar Hypertrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tonsillectomy, Tonsillotomy.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Tonsillar Hypertrophy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Tonsillectomy
    Standard tonsillectomy
  • Procedure Tonsillotomy
    Tonsillotomy

Primary outcome measures

  • Postoperative hemorrhage [Time frame: 14 days]
  • Postoperative pain [Time frame: 30 days]
  • Recovery time - Sick leave [Time frame: 30 days]
  • Morbidity [Time frame: 30 days]
Secondary outcome measures (2)
  • AHI [Time frame: 180 days]
  • DISE - VOTE [Time frame: 180 days]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. PMID 27188535
  • Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080. PMID 11991871
  • Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901. PMID 10805822
  • Fietze I, Laharnar N, Obst A, Ewert R, Felix SB, Garcia C, Glaser S, Glos M, Schmidt CO, Stubbe B, Volzke H, Zimmermann S, Penzel T. Prevalence and association analysis of obstructive sleep apnea with gender and age differences - Results of SHIP-Trend. J Sleep Res. 2019 Oct;28(5):e12770. doi: 10.1111/jsr.12770. Epub 2018 Oct 1. PMID 30272383
  • Drager LF, McEvoy RD, Barbe F, Lorenzi-Filho G, Redline S; INCOSACT Initiative (International Collaboration of Sleep Apnea Cardiovascular Trialists). Sleep Apnea and Cardiovascular Disease: Lessons From Recent Trials and Need for Team Science. Circulation. 2017 Nov 7;136(19):1840-1850. doi: 10.1161/CIRCULATIONAHA.117.029400. PMID 29109195
  • Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004 Apr 28;291(16):2013-6. doi: 10.1001/jama.291.16.2013. No abstract available. PMID 15113821
  • Van Ryswyk E, Anderson CS, Antic NA, Barbe F, Bittencourt L, Freed R, Heeley E, Liu Z, Loffler KA, Lorenzi-Filho G, Luo Y, Margalef MJM, McEvoy RD, Mediano O, Mukherjee S, Ou Q, Woodman R, Zhang X, Chai-Coetzer CL. Predictors of long-term adherence to continuous positive airway pressure in patients with obstructive sleep apnea and cardiovascular disease. Sleep. 2019 Oct 9;42(10):zsz152. doi: 10.10 PMID 31587046
  • Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG. PMID 18250209

Identifiers

NCT: NCT06376383 · TETT-RHG · 110500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗