Clinical trial NCT05535634: Sound Ear Check (SEC) in Hearing Diagnostics in Young Children
Official title: Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss
Otitis Media With Effusion
Tympanostomy
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Otherwise healthy 3-10 years old children referred to tympanostomy tube insertion

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).

Eligibility criteria: Inclusion Criteria:

* Finnish speaking (child and parent)

Exclusion Criteria:

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

Primary outcomes:
measure: SNR
timeFrame: 1-2 months
Secondary outcomes:
measure: Otitis media 6 questionnaire
timeFrame: 1-2 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery
Study officials:
affiliation: Hospital District of Southwest Finland
name: Lotta Haavisto, PhD
role: PRINCIPAL_INVESTIGATOR
References: