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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sound Ear Check | Diagnostic Test | Hearing test, measurement of the input impedance of the middle-ear transmission system |
|
| Measure | Description | Time Frame |
|---|---|---|
| SNR | Signal to noise ratio | 1-2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Otitis media 6 questionnaire | questionnaire | 1-2 months |
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Inclusion Criteria:
Exclusion Criteria:
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Otherwise healthy 3-10 years old children referred to tympanostomy tube insertion
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lotta Haavisto, PhD | Contact | +358 23130000 | lotta.haavisto@tyks.fi | |
| Vesa Lahdes, M.D. | Contact | +358 23130000 | vesa.lahdes@tyks.fi |
| Name | Affiliation | Role |
|---|---|---|
| Lotta Haavisto, PhD | Hospital District of Southwest Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery | Recruiting | Turku | Finland |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D000158 | Acoustic Impedance Tests |
| ID | Term |
|---|---|
| D006320 | Hearing Tests |
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010033 | Otitis Media |
| D010031 | Otitis |