Sound Ear Check (SEC) in Hearing Diagnostics in Young Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sound Ear Check.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Otitis Media With Effusion, Tympanostomy. Basic parameters: 3 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion
Overview
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).
Interventions
- Diagnostic test Sound Ear Check
Hearing test, measurement of the input impedance of the middle-ear transmission system
Primary outcome measures
- SNR [Time frame: 1-2 months]
Secondary outcome measures (1)
- Otitis media 6 questionnaire [Time frame: 1-2 months]
Eligibility criteria
Inclusion criteria
- Finnish speaking (child and parent)
Exclusion criteria
- Prior sensorineural hearing loss
- developmental disorder
- Prior ear surgery (except tympanostomy insertion)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Finland · 1 center
- Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery — Turku
Identifiers
NCT: NCT05535634 · T9/2022