Littlears Auditory Questionnaire: Validation Study in CI Children

Study Overview
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Brief Summary
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The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years. The questionnaire has been validated on children with normal hearing whose native language is German. A comparison was made between North American English speaking children with normal hearing and found that it was consistent with the German data. This study is to validate the questionnaire in children with cochlear implants.

Official Title
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Littlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English

Conditions
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Hearing Loss

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General: Less than or 24 months of age prior to implantation Cochlear implant candidate deemed by the clinic To be implanted with a MED-EL cochlear implant PULSARCI100 or SONATATI100 English as the primary language at home Realistic expectations of guardians Willing and available to comply with all scheduled procedures as defined in the protocol Medical: Good general health status, as judged by Primary Investigator No contraindications for surgery, in general, or cochlear implant surgery in particular Exclusion Criteria: General: Prior experience with any cochlear implant system Older than 24 months at time of implantation Medical: Severed or non-functional auditory nerve in the ear(s) to be implanted Cognitive and/or neurological dysfunction

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cochlear implant<br>children less than 24 months at time of cochlear implantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Validate the LittleEARS Auditory Questionnaire | The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting | The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensorineural hearing loss, cochlear implant