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

Recruiting

• Conditions: Adenoidectomy; Tonsillectomy; Eustachian Tube Dysfunction

• Registration Number: NCT05600595
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

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.

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-18
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tympanogram	6 weeks after operation	Acoustic immittance test

Secondary Outcome Measures

Name	Time	Method
Eustachian tube inflammation	6 weeks after operation	Divided into 0=normal, 1=mild, 2=moderate, 3=severe
EDTQ-7 symptom score	6 weeks after operation	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

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, China