Actively Recruiting

Age: 3Years - 10Years
All Genders
Healthy Volunteers
ID05535634

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

Led by Vesa Lahdes · Updated on 2022-09-10

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the Sound Ear Check (SEC), an automated, tablet-based hearing test that uses common non-speech sounds and pictures to assess hearing in children aged 3 to 10 years who are otherwise healthy but referred for tympanostomy tube insertion. The study focuses on comparing hearing test results before surgery, when middle ear fluid is present, and one month after surgery, when the middle ear is dry with a ventilation tube. The purpose is to understand how SEC results relate to middle ear conditions and quality of life in children with otitis media. Participants will undergo the SEC hearing test using normal and antiphasic sounds before their tympanostomy tube insertion (TTI) surgery. The test will be repeated one month after surgery during a control visit. Middle ear fluid found during surgery will be classified as serous, mucous, or purulent. Tympanometry, which measures middle ear function, will be performed before surgery and classified using the Jerger classification. Medical history and ear-related quality of life will be recorded through interviews and the Otitis Media 6 (OM-6) questionnaire, collected at both the beginning of the study and the one month follow-up. Throughout the study, children will be assessed for cooperation during tympanometry and SEC testing. Data collection includes hospital records, interviews, and web-based questionnaires. The main measurement is the signal-to-noise ratio (SNR) from the SEC test at 1 to 2 months post-surgery. The OM-6 questionnaire will also be used to evaluate quality of life changes related to ear health. Participants' involvement lasts from before the TTI operation through the one month control visit, with all assessments done during these visits.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child and parent speak Finnish
  • Child is aged between 3 and 10 years
  • Child is otherwise healthy and referred for tympanostomy tube insertion
Not Eligible

You will not qualify if you...

  • Prior sensorineural hearing loss
  • Developmental disorder
  • Prior ear surgery except tympanostomy insertion

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day before surgery

Participants undergo Sound Ear Check (SEC) hearing tests and tympanometric measurements before the tympanostomy tube insertion operation. Medical history and ear-related quality of life questionnaires are collected at this time.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day

Participants undergo tympanostomy tube insertion surgery during which middle ear fluid is classified. SEC and tympanometric testing are also performed while waiting for the operation.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 1 month

Participants are retested with SEC and complete the ear-related quality of life questionnaire approximately one month after surgery when middle ears are checked to be dry with ventilation tubes.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Turku, Finland

Actively Recruiting

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Research Team

L

Lotta Haavisto, PhD

V

Vesa Lahdes, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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