Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05535634
Study type Observational
Source Turku University Hospital
Contact Lotta Haavisto, PhD
Phone +358 23130000
Email lotta.haavisto@tyks.fi
Status Recruiting
Phase
Start date August 31, 2022
Completion date December 31, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT04696835 - fNIRS in Pediatric Hearing Aids N/A
Completed NCT03662256 - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine N/A
Completed NCT04602780 - Evaluating the Revised WORQ in CI Users
Completed NCT03723161 - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed NCT05086809 - Investigation of an Updated Bone-anchored Sound Processor N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03428841 - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients N/A
Completed NCT04559282 - Home Test of New Sound Processor N/A
Enrolling by invitation NCT03345654 - Individually-guided Hearing Aid Fitting
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Completed NCT05165121 - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids N/A
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Completed NCT04622059 - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis N/A
Terminated NCT02294812 - Effects of Cognitive Training on Speech Perception N/A
Recruiting NCT02558478 - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing N/A
Withdrawn NCT02740322 - Validating the Hum Test N/A
Completed NCT01963104 - Community-Based Kiosks for Hearing Screening and Education N/A
Completed NCT01857661 - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial N/A
Completed NCT01892007 - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users N/A
Withdrawn NCT01223638 - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism N/A