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AdenoidectomyNCT05600595

The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring Operation in Children

An observational study of Adenoidectomy and Tonsillectomy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate and screen out the factors related to the improvement of eustachian tube function after adenoidectomy and/or tonsillectomy, so as to guide the treatment of children's eustachian tube function before and after operation, and provide the treatment direction and methods for diseases related to… Read more about this study

Who is it for?
Ages 3 to 14 years
What is being tested?
Operation for snoring in children
Type of treatment
Surgery or procedure
How many people
450 participants
Where
1 siteChina
Study dates
18 Oct 2022to 30 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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 3 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with snoring complicated with eustachian tube dysfunction

Who may be able to join

  • ① Age 3-14 years old.
  • ② Patients diagnosed as snoring or adenoid hypertrophy in children, tonsil hypertrophy and chronic tonsillitis who are to be treated by adenoidectomy or tonsillectomy or tonsillectomy;
  • ③ Conform to 1. Symptoms: snoring during sleep, breathing with mouth open, some with apnea, restless sleep, and a few children with hearing loss. 2. Fiberoptic nasopharyngoscopy showed adenoids and/or tonsil hypertrophy. 3. No family history of deafness, no history of ototoxic drugs. 4. No external ear and maxillofacial deformity. 5. The tympanic pressure curve is "C" or "B". 6. No suppurative medium.
  • Auricular inflammation and tympanic membrane perforation; Adhesive otitis media, cholesteatoma of middle ear.
  • ④ Patients' families cooperated well.
  • ⑤ The patient's guardian volunteered to participate in this study and signed the informed consent form.

Who cannot join

  • Middle ear catheterization or puncture was performed at the same time;
  • Eustachian atresia or cleft lip and palate; There are craniofacial abnormalities or neuromuscular diseases;
  • Benign and malignant tumors of nose or nasopharynx;
  • Other middle ear diseases (suppurative otitis media, tympanic membrane perforation; Adhesive otitis media, middle ear cholesteatoma, etc.); ⑤ Those who can't cooperate; ⑥ Previous tonsil and adenoid surgery; ⑦ Upper respiratory tract infection in recent two weeks; ⑧ Any other circumstances that researchers think should be excluded from this study;

Trial locations and contacts

1 site in 1 country.

Hao Xiong contact

13725130384

xiongh7@mail.sysu.edu.cn

Wenting Deng contact

15017556968

dengwt23@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou

    Hao Xiong, doctorate, 13725130384, xiongh7@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring in Children

This study aims to evaluate and screen out the factors related to the improvement of eustachian tube function after adenoidectomy and/or tonsillectomy, so as to guide the treatment of children's eustachian tube function before and after operation, and provide the treatment direction and methods for diseases related to eustachian tube dysfunction for people with adenoid hypertrophy and/or tonsil hypertrophy complicated with ETD.

Read the detailed description

This study aims to analyze the changes of eustachian tube function in children with snoring and eustachian tube dysfunction before and after snoring surgery, and to evaluate and screen out the related factors related to the improvement of eustachian tube function after snoring surgery. The patients who were admitted to hospital and diagnosed as children's snoring complicated with diseases related to eustachian tube dysfunction and planned to undergo surgical treatment for children's snoring should be included, and relevant examinations should be improved, including preoperative nasopharyngoscope, otoscope, acoustic immittance and pure tone audiometry. After snoring operation, he returned to the hospital at 6, 12 and 24 weeks after operation for reexamination of nasopharyngoscope, otoscope, acoustic immittance, pure tone audiometry and TMM. The patients were assessed with ETDQ-7 score, ETS-7 score and VAS score by self-administered questionnaire. The effective risk-related factors were screened out by single factor and multi-factor Logistics regression analysis. To guide the treatment of children's eustachian tube function before and after operation, and to provide the treatment direction and methods for children's snoring diseases complicated with ETD.

Being tested
Operation for snoring in children
Keywords
Eustachian Tube Dysfunction, Snoring in children

What participants receive

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

  • Operation for snoring in childrenProcedure or surgery

    Tonsillectomy and/or adenoidectomy

What is being measured

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

  1. Tympanogram

    Acoustic immittance test

    Measured: 6 weeks after operation

Secondary outcomes (2)

  1. EDTQ-7 symptom score

    1. Pressure in the ears?
    2. Pain in the ears?
    3. A feeling that your ears are clogged or 'under water'?
    4. Ear symptoms when you have a cold or sinusitis?
    5. Crackling or popping sounds in the ears?
    6. Ringing in the ears?
    7. A feeling that your hearing is muffled

    Measured: 6 weeks after operation

  2. Eustachian tube inflammation

    Divided into 0=normal, 1=mild, 2=moderate, 3=severe

    Measured: 6 weeks after operation

Timeline

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

  1. First posted31 Oct 2022
  2. Study start18 Oct 2022
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05600595
Sponsor's protocol ID
SYSKY-2022-350-01
Status last verified
Oct 2022
First submitted
27 Oct 2022
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope. 2010 Jul;120(7):1411-6. doi: 10.1002/lary.20950.

    PubMed 20564474

  • Bluestone CD,Bluestone MB. Eustachian tube：structure，function，role in otitis media. NY：BC Decker，2005

  • Mansour S，Magnan J，Haidar H，et al. Tympanic membrane retraction pocket. Springer International Publishing，2015：17

  • Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902. doi: 10.1097/MAO.0000000000001853.

    PubMed 29912819

  • Alper CM, Luntz M, Takahashi H, Ghadiali SN, Swarts JD, Teixeira MS, Csakanyi Z, Yehudai N, Kania R, Poe DS. Panel 2: Anatomy (Eustachian Tube, Middle Ear, and Mastoid-Anatomy, Physiology, Pathophysiology, and Pathogenesis). Otolaryngol Head Neck Surg. 2017 Apr;156(4_suppl):S22-S40. doi: 10.1177/0194599816647959.

    PubMed 28372527

  • D'Alatri L, Picciotti PM, Marchese MR, Fiorita A. Alternative treatment for otitis media with effusion: eustachian tube rehabilitation. Acta Otorhinolaryngol Ital. 2012 Feb;32(1):26-30.

    PubMed 22500063

  • Schroder S, Lehmann M, Sauzet O, Ebmeyer J, Sudhoff H. A novel diagnostic tool for chronic obstructive eustachian tube dysfunction-the eustachian tube score. Laryngoscope. 2015 Mar;125(3):703-8. doi: 10.1002/lary.24922. Epub 2014 Sep 12.

    PubMed 25215457

  • Cayir S, Hizli O, Kayabasi S, Yildirim G. Eustachian tube dysfunction in sleep apnea patients and improvements afforded by continuous positive airway pressure therapy. Braz J Otorhinolaryngol. 2021 May-Jun;87(3):333-337. doi: 10.1016/j.bjorl.2020.02.003. Epub 2020 Mar 12.

    PubMed 32247766

  • Robison JG, Wilson C, Otteson TD, Chakravorty SS, Mehta DK. Increased eustachian tube dysfunction in infants with obstructive sleep apnea. Laryngoscope. 2012 May;122(5):1170-7. doi: 10.1002/lary.22473. Epub 2012 Feb 16.

    PubMed 22344711

  • Ahmed ST, Lin J, Moskowitz HS, Stupak HD. Can the negative pressures found in obstructive sleep apnea and Eustachian tube dysfunction be related? Am J Otolaryngol. 2021 Jul-Aug;42(4):102993. doi: 10.1016/j.amjoto.2021.102993. Epub 2021 Feb 18.

    PubMed 33640801

Questions about this trial

What is this clinical trial studying?

An observational study of Adenoidectomy and Tonsillectomy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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

Contact Hao Xiong (13725130384, xiongh7@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tympanogram (time frame: 6 weeks after operation). 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 NCT05600595, which also lists 10 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 31 Oct 2022.

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