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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05535634
Other study ID # T9/2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 31, 2022
Est. completion date December 31, 2028

Study information

Verified date September 2022
Source Turku University Hospital
Contact Lotta Haavisto, PhD
Phone +358 23130000
Email lotta.haavisto@tyks.fi
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion Criteria: - Finnish speaking (child and parent) Exclusion Criteria: - Prior sensorineural hearing loss - developmental disorder - Prior ear surgery (except tympanostomy insertion)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Sound Ear Check
Hearing test, measurement of the input impedance of the middle-ear transmission system

Locations

Country Name City State
Finland Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery Turku

Sponsors (1)

Lead Sponsor Collaborator
Vesa Lahdes

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary SNR Signal to noise ratio 1-2 months
Secondary Otitis media 6 questionnaire questionnaire 1-2 months
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