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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05600595
Collaborator
Guangzhou Women and Children's Medical Center (Other), Xiaolan People's Hospital of Zhongshan City (Other)
450
1
26.4
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Operation for snoring in children

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 Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring in Children
Actual Study Start Date :
Oct 18, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Tympanogram [6 weeks after operation]

    Acoustic immittance test

Secondary Outcome Measures

  1. EDTQ-7 symptom score [6 weeks after operation]

    Pressure in the ears? Pain in the ears? A feeling that your ears are clogged or 'under water'? Ear symptoms when you have a cold or sinusitis? Crackling or popping sounds in the ears? Ringing in the ears? A feeling that your hearing is muffled

  2. Eustachian tube inflammation [6 weeks after operation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen Memorial Hospital of Sun Yat-sen University Guangzhou China

Sponsors and Collaborators

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

Investigators

  • Study Chair: Hao Xiong, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05600595
Other Study ID Numbers:
  • SYSKY-2022-350-01
First Posted:
Oct 31, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2022