Sound Ear Check (SEC) in Hearing Diagnostics in Young Children
NCT ID: NCT05535634
Last Updated: 2022-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-08-31
2028-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Children referred for tympanostomy tube insertion
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.
Sound Ear Check
Hearing test, measurement of the input impedance of the middle-ear transmission system
Interventions
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Sound Ear Check
Hearing test, measurement of the input impedance of the middle-ear transmission system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* developmental disorder
* Prior ear surgery (except tympanostomy insertion)
3 Years
10 Years
ALL
Yes
Sponsors
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Vesa Lahdes
OTHER_GOV
Responsible Party
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Vesa Lahdes
M.D.
Principal Investigators
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Lotta Haavisto, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital District of Southwest Finland
Locations
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Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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T9/2022
Identifier Type: -
Identifier Source: org_study_id
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