Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea
NCT ID: NCT06376383
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
464 participants
INTERVENTIONAL
2025-01-31
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tonsillectomy
Patients undergo standard removal of subcapsular removal of palatine tonsils
Tonsillectomy
Standard tonsillectomy
Tonsillotomy
Patients undergo intracapsular reduction of palatine tonsils
Tonsillotomy
Tonsillotomy
Interventions
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Tonsillectomy
Standard tonsillectomy
Tonsillotomy
Tonsillotomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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: 10.1093/sleep/zsz152.
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.
Kezirian EJ, Hohenhorst W, de Vries N. Drug-induced sleep endoscopy: the VOTE classification. Eur Arch Otorhinolaryngol. 2011 Aug;268(8):1233-1236. doi: 10.1007/s00405-011-1633-8. Epub 2011 May 26.
Lechner M, Wilkins D, Kotecha B. A review on drug-induced sedation endoscopy - Technique, grading systems and controversies. Sleep Med Rev. 2018 Oct;41:141-148. doi: 10.1016/j.smrv.2018.02.001. Epub 2018 Feb 24.
MacKay S, Carney AS, Catcheside PG, Chai-Coetzer CL, Chia M, Cistulli PA, Hodge JC, Jones A, Kaambwa B, Lewis R, Ooi EH, Pinczel AJ, McArdle N, Rees G, Singh B, Stow N, Weaver EM, Woodman RJ, Woods CM, Yeo A, McEvoy RD. Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial. JAMA. 2020 Sep 22;324(12):1168-1179. doi: 10.1001/jama.2020.14265.
Rashwan MS, Montevecchi F, Cammaroto G, Badr El Deen M, Iskander N, El Hennawi D, El Tabbakh M, Meccariello G, Gobbi R, Stomeo F, Vicini C. Evolution of soft palate surgery techniques for obstructive sleep apnea patients: A comparative study for single-level palatal surgeries. Clin Otolaryngol. 2018 Apr;43(2):584-590. doi: 10.1111/coa.13027. Epub 2017 Dec 3.
Camacho M, Li D, Kawai M, Zaghi S, Teixeira J, Senchak AJ, Brietzke SE, Frasier S, Certal V. Tonsillectomy for adult obstructive sleep apnea: A systematic review and meta-analysis. Laryngoscope. 2016 Sep;126(9):2176-86. doi: 10.1002/lary.25931. Epub 2016 Mar 22.
Reckley LK, Fernandez-Salvador C, Camacho M. The effect of tonsillectomy on obstructive sleep apnea: an overview of systematic reviews. Nat Sci Sleep. 2018 Apr 4;10:105-110. doi: 10.2147/NSS.S127816. eCollection 2018.
Sjoblom HM, Nahkuri M, Suomela M, Jero J, Piitulainen JM. Treatment of sleep apnoea with tonsillectomy: a retrospective analysis using long-term follow-up data. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3727-3732. doi: 10.1007/s00405-022-07350-6. Epub 2022 Mar 25.
Randall DA, Hoffer ME. Complications of tonsillectomy and adenoidectomy. Otolaryngol Head Neck Surg. 1998 Jan;118(1):61-8. doi: 10.1016/S0194-5998(98)70376-6.
Myssiorek D, Alvi A. Post-tonsillectomy hemorrhage: an assessment of risk factors. Int J Pediatr Otorhinolaryngol. 1996 Sep;37(1):35-43. doi: 10.1016/0165-5876(96)01364-x.
Zhang LY, Zhong L, David M, Cervin A. Tonsillectomy or tonsillotomy? A systematic review for paediatric sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2017 Dec;103:41-50. doi: 10.1016/j.ijporl.2017.10.008. Epub 2017 Oct 5.
Wang H, Fu Y, Feng Y, Guan J, Yin S. Tonsillectomy versus tonsillotomy for sleep-disordered breathing in children: a meta analysis. PLoS One. 2015 Mar 25;10(3):e0121500. doi: 10.1371/journal.pone.0121500. eCollection 2015.
Acevedo JL, Shah RK, Brietzke SE. Systematic review of complications of tonsillotomy versus tonsillectomy. Otolaryngol Head Neck Surg. 2012 Jun;146(6):871-9. doi: 10.1177/0194599812439017. Epub 2012 Mar 6.
Wong Chung JERE, van Benthem PPG, Blom HM. Tonsillotomy versus tonsillectomy in adults suffering from tonsil-related afflictions: a systematic review. Acta Otolaryngol. 2018 May;138(5):492-501. doi: 10.1080/00016489.2017.1412500. Epub 2017 Dec 15.
Other Identifiers
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110500
Identifier Type: OTHER
Identifier Source: secondary_id
TETT-RHG
Identifier Type: -
Identifier Source: org_study_id
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