Sound Ear Check (SEC) in Hearing Diagnostics in Young Children
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 10, 2022
September 1, 2022
6.3 years
September 7, 2022
September 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
SNR
Signal to noise ratio
1-2 months
Secondary Outcomes (1)
Otitis media 6 questionnaire
1-2 months
Study Arms (1)
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.
Interventions
Hearing test, measurement of the input impedance of the middle-ear transmission system
Eligibility Criteria
Otherwise healthy 3-10 years old children referred to tympanostomy tube insertion
You may qualify if:
- Finnish speaking (child and parent)
You may not qualify if:
- Prior sensorineural hearing loss
- developmental disorder
- Prior ear surgery (except tympanostomy insertion)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vesa Lahdeslead
Study Sites (1)
Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery
Turku, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lotta Haavisto, PhD
Hospital District of Southwest Finland
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 10, 2022
Study Start
August 31, 2022
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
September 10, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share