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

Last updated: October 27, 2022
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ear, Nose, And Throat (Ent) Surgeries

Ear Infections (Pediatric)

Ear Infections

Treatment

N/A

Clinical Study ID

NCT05600595
SYSKY-2022-350-01
  • Ages 3-14
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

① Age 3-14 years old.

② Patients diagnosed as snoring or adenoid hypertrophy in children, tonsil hypertrophy andchronic tonsillitis who are to be treated by adenoidectomy or tonsillectomy ortonsillectomy;

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 nasopharyngoscopyshowed adenoids and/or tonsil hypertrophy. 3. No family history of deafness, no history ofototoxic drugs. 4. No external ear and maxillofacial deformity. 5. The tympanic pressurecurve 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 informedconsent form.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 450
Study Start date:
October 18, 2022
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

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

    Guangzhou,
    China

    Active - Recruiting

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