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Obstructive Sleep ApneaNCT06376383

Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

A study testing Tonsillectomy and Tonsillotomy in people with Obstructive Sleep Apnea and Tonsillar Hypertrophy, run by University of Aarhus.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Tonsillectomy and Tonsillotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
464 participants
Where
No sites listed yet
Study dates
Jan 2025to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kasra Zainali-Gill, Ph.D contact

+4578439744

kasrzain@rm.dk

About this study

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

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.

Being tested
Tonsillectomy, Tonsillotomy
Keywords
Tonsillectomy, Obstructive sleep apnea (OSA), Tonsillotomy, Intracapsular reduction of tonsils, Drug Induced Sedation Endoscopy
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TonsillectomyProcedure or surgery

    Also called TE

    Standard tonsillectomy

  • TonsillotomyProcedure or surgery

    Also called TT

    Tonsillotomy

Study groups in NCT06376383
Study groupRoleWhat they receive
TonsillectomyActive comparatorPatients undergo standard removal of subcapsular removal of palatine tonsils
Receives: Procedure: Tonsillectomy
TonsillotomyExperimentalPatients undergo intracapsular reduction of palatine tonsils
Receives: Procedure: Tonsillotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative hemorrhage

    Postoperative hemorrhage event - readmission to the hospital

    Measured: 14 days

  2. Postoperative pain

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

    Measured: 30 days

  3. Recovery time - Sick leave

    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

    Measured: 30 days

  4. Morbidity

    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

    Measured: 30 days

Secondary outcomes (2)

  1. AHI

    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

    Measured: 180 days

  2. DISE - VOTE

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

    1. = partial collaps
    2. = complete collaps

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
464 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376383
Sponsor's protocol ID
TETT-RHG
Other IDs
110500
Status last verified
Apr 2024
First submitted
9 Apr 2024
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.1093/sleep/zsz152.

    PubMed 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.

    PubMed 18250209

  • 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.

    PubMed 21614467

  • 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.

    PubMed 29627276

  • 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.

    PubMed 32886102

  • 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.

    PubMed 29106778

  • 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.

    PubMed 27005314

  • 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.

    PubMed 29670412

  • 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.

    PubMed 35338397

Questions about this trial

What is this clinical trial studying?

A study testing Tonsillectomy and Tonsillotomy in people with Obstructive Sleep Apnea and Tonsillar Hypertrophy, run by University of Aarhus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kasra Zainali-Gill, Ph.D (+4578439744, kasrzain@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative hemorrhage (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376383, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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