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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cochlear implant | children less than 24 months at time of cochlear implantation |
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| 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 |
| 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. |
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Inclusion Criteria:
General:
Medical:
Exclusion Criteria:
General:
Medical:
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Children under the age of 24 months at time of cochlear implantation recommended by the cochlear implant clinic.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Health Sciences University | Augusta | Georgia | 30912 | United States | ||
| University of North Carolina-Chapel Hill/CCCDP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fisseni HJ. (1998) Lehrbuch der psychologischen Diagnostik, Göttingen, Hogrefe. | ||
| Background | Kühn-Inacker H, Weichbold V, Tsaikpini L, Coninx F, D'Hease P. (2003) LittlEARS Hörfragebogen - Handanweisung. MED-EL Headquarters, Innsbruck, Austria. | ||
| 15909244 | Background | Weichbold V, Tsiakpini L, Coninx F, D'Haese P. [Development of a parent questionnaire for assessment of auditory behaviour of infants up to two years of age]. Laryngorhinootologie. 2005 May;84(5):328-34. doi: 10.1055/s-2004-826232. German. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cochlear Implant | children less than 24 months at time of cochlear implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cochlear Implant | children less than 24 months at time of cochlear implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | 24 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cochlear Implant | children less than 24 months at time of cochlear implantation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Research Associate | MED-EL Corporation | clinicaltrials@medelus.com |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 24 months |
| Durham |
| North Carolina |
| 27713 |
| United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | Posted | Mean | Full Range | units on a scale | 24 months |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |