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

NCT05600595 | Unknown DMC

• 1 other identifier: SYSKY-2022-350-01
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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 eustachian tube dysfunction for people with adenoid hypertrophy and/or tonsil hypertrophy complicated with ETD.

Conditions

Adenoidectomy; Tonsillectomy; Eustachian Tube Dysfunction

Keywords

Eustachian Tube Dysfunction; Snoring in children

Outcome Measures

Primary Outcomes (1)

• Tympanogram

  Acoustic immittance test

  6 weeks after operation

Secondary Outcomes (2)

• EDTQ-7 symptom score

  6 weeks after operation

• Eustachian tube inflammation

  6 weeks after operation

Interventions

Operation for snoring in children PROCEDURE

Tonsillectomy and/or adenoidectomy

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with snoring complicated with eustachian tube dysfunction

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Guangzhou Women and Children's Medical Center: collaborator
• Xiaolan People's Hospital of Zhongshan City: collaborator

Study Sites (1)

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

Guangzhou, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 20564474 RESULT

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

  RESULT

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

  RESULT

• 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.

  PMID: 29912819 RESULT

• 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.

  PMID: 28372527 RESULT

• 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.

  PMID: 22500063 RESULT

• 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.

  PMID: 25215457 RESULT

• 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.

  PMID: 32247766 RESULT

• 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.

  PMID: 22344711 RESULT

• 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.

  PMID: 33640801 RESULT

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Hao Xiong

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Hao Xiong

CONTACT

13725130384; xiongh7@mail.sysu.edu.cn

Wenting Deng

CONTACT

15017556968; dengwt23@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: October 31, 2022
• Study Start: October 18, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)