Sound Ear Check (SEC) in Hearing Diagnostics in Young Children

Recruiting

• Conditions: Otitis Media With Effusion; Hearing Loss; Tympanostomy
• Interventions: Diagnostic Test: Sound Ear Check

• Registration Number: NCT05535634
• Lead Sponsor: Vesa Lahdes

Brief Summary

Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.

Detailed Description

Sound Ear Check (SEC) is an automated tablet-based self-test that uses common nonspeech sounds (ecological sounds) that are accompanied by pictures that are easily recognizable even for younger children.

Before TTI operation, each participant will be tested with SEC using normal (dichotic) sounds and antiphasic sounds. Results will be compared to middle ear findings and the test will be repeated one month after the operation when the middle ears are checked to be dry (with a ventilation tube). At the time of the myringotomy during TTI operation, possible middle ear fluid will be classified as serous (transparent, clear), mucous (thick) or purulent (consisting of pus). A tympanometry will be performed within the same visit as the SEC measurement before the TTI operation. At the time of tympanometric examination, each participant will be classified as cooperative (sittings still, not crying, not resisting) or non-cooperative. Tympanometric findings will be classified after the Jerger classification. SEC and tympanometric testing is designed to be performed at the same visit as TTI operation as patients will be waiting for the operation at the ward. Medical history of the study patients will be collected from the hospital patient records and through interview and questionnaires to the subjects. Ear related quality of life questionnaire (OM-6) will be performed at the beginning of the study and the one month control visit. Questionnaires are collected using web-based REDCap -software (Research Electronic Data Capture).

Study Timeline

• Study Start: 2022-08-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Last Update Submitted: 2022-09-07
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Finnish speaking (child and parent)

Exclusion Criteria

• Prior sensorineural hearing loss
• developmental disorder
• Prior ear surgery (except tympanostomy insertion)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children referred for tympanostomy tube insertion	Sound Ear Check	Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.

Primary Outcome Measures

Name	Time	Method
SNR	1-2 months	Signal to noise ratio

Secondary Outcome Measures

Name	Time	Method
Otitis media 6 questionnaire	1-2 months	questionnaire

Trial Locations

Locations (1)

Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery; 🇫🇮 Turku, Finland