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

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

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss; Otitis Media With Effusion; Tympanostomy
• Intervention / Treatment: Diagnostic test: Sound Ear Check

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).

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Lotta Haavisto, PhD; Phone Number: +358 23130000; Email: lotta.haavisto@tyks.fi
• Study Contact Backup: Name: Vesa Lahdes, M.D.; Phone Number: +358 23130000; Email: vesa.lahdes@tyks.fi

Study Locations

• Finland
  • Turku, Finland
    • Recruiting
    • Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery
    • Contact: Lotta Haavisto, PhD; Phone Number: +35823130000; Email: lotta.haavisto@tyks.fi
    • Contact: Vesa Lahdes, M.D.; Phone Number: +35823130000; Email: vesa.lahdes@tyks.fi
    • Principal Investigator: Tytti Willberg, M.D.
    • Principal Investigator: Vesa Lahdes, M.D.
    • Principal Investigator: Tuomo Puhakka, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Otherwise healthy 3-10 years old children referred to tympanostomy tube insertion

Description

Inclusion Criteria:

• Finnish speaking (child and parent)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Sound Ear Check; Hearing test, measurement of the input impedance of the middle-ear transmission system; Other Names: Tympanometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNR	Signal to noise ratio	1-2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Otitis media 6 questionnaire	questionnaire	1-2 months

Collaborators and Investigators

• Sponsor: Vesa Lahdes
• Investigators: Principal Investigator: Lotta Haavisto, PhD, Hospital District of Southwest Finland

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Otitis; Hearing Disorders; Hearing Loss; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: T9/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No