Clinical trial NCT00785707: Littlears Auditory Questionnaire: Validation Study in CI Children
Official title: Littlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: sensorineural hearing loss
cochlear implant
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 31
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under the age of 24 months at time of cochlear implantation recommended by the cochlear implant clinic.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To Validate the LittleEARS Auditory Questionnaire
timeFrame: 24 months
Secondary outcomes:
measure: Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting
timeFrame: 24 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Durham
country: United States
facility: University of North Carolina-Chapel Hill/CCCDP
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Fisseni HJ. (1998) Lehrbuch der psychologischen Diagnostik, Göttingen, Hogrefe.
citation: Kühn-Inacker H, Weichbold V, Tsaikpini L, Coninx F, D'Hease P. (2003) LittlEARS Hörfragebogen - Handanweisung. MED-EL Headquarters, Innsbruck, Austria.
citation: 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.