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NCT Number: NCT05535634

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

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery

Turku, Finland

Location status: Recruiting

Location contact

Lotta Haavisto, PhD

CONTACT

[email protected]

+35823130000

Tuomo Puhakka, PhD

PRINCIPAL_INVESTIGATOR

Tytti Willberg, M.D.

PRINCIPAL_INVESTIGATOR

Vesa Lahdes, M.D.

CONTACT

[email protected]

+35823130000

Vesa Lahdes, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Finnish speaking (child and parent)

Exclusion criteria

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

Treatment and study plan

Sound Ear Check

Diagnostic Test

Hearing test, measurement of the input impedance of the middle-ear transmission system

Other names: Tympanometry

Primary outcomes

  1. SNR

    Time frame: 1-2 months

    Signal to noise ratio

Secondary outcomes

  1. Otitis media 6 questionnaire

    Time frame: 1-2 months

    questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Lotta Haavisto, PhD

CONTACT

[email protected]

+358 23130000

Vesa Lahdes, M.D.

CONTACT

[email protected]

+358 23130000

Sponsors and collaborators

Lead sponsor

Vesa Lahdes

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2022
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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