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

Hearing Loss Clinical Trial

Official title:

Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05535634
• Other study ID #: T9/2022
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Hearing Loss
• Otitis Media
• Otitis Media with Effusion

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