Hearing Loss Clinical Trial
Official title:
Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion
NCT number | NCT05535634 |
Other study ID # | T9/2022 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 31, 2022 |
Est. completion date | December 31, 2028 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 10 Years |
Eligibility | Inclusion Criteria: - Finnish speaking (child and parent) Exclusion Criteria: - Prior sensorineural hearing loss - developmental disorder - Prior ear surgery (except tympanostomy insertion) |
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery | Turku |
Lead Sponsor | Collaborator |
---|---|
Vesa Lahdes |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SNR | Signal to noise ratio | 1-2 months | |
Secondary | Otitis media 6 questionnaire | questionnaire | 1-2 months |
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