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

NCT ID: NCT05600595

Last Updated: 2022-10-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-18

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adenoidectomy Tonsillectomy Eustachian Tube Dysfunction

Keywords

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Eustachian Tube Dysfunction Snoring in children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Operation for snoring in children

Tonsillectomy and/or adenoidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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;
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Xiaolan People's Hospital of Zhongshan City

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hao Xiong

Role: STUDY_CHAIR

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

Locations

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

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Xiong

Role: CONTACT

Phone: 13725130384

Email: [email protected]

Wenting Deng

Role: CONTACT

Phone: 15017556968

Email: [email protected]

Facility Contacts

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Hao Xiong, doctorate

Role: primary

References

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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.

Reference Type RESULT
PMID: 20564474 (View on PubMed)

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

Reference Type RESULT

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

Reference Type 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.

Reference Type RESULT
PMID: 29912819 (View on PubMed)

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.

Reference Type RESULT
PMID: 28372527 (View on PubMed)

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.

Reference Type RESULT
PMID: 22500063 (View on PubMed)

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.

Reference Type RESULT
PMID: 25215457 (View on PubMed)

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.

Reference Type RESULT
PMID: 32247766 (View on PubMed)

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.

Reference Type RESULT
PMID: 22344711 (View on PubMed)

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.

Reference Type RESULT
PMID: 33640801 (View on PubMed)

Other Identifiers

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SYSKY-2022-350-01

Identifier Type: -

Identifier Source: org_study_id