Littlears Auditory Questionnaire: Validation Study in CI Children

Hearing Loss Clinical Trial

— LittlEars  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785707
• Other study ID #: MED-EL NA 020
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: March 4, 2016
• Start date: May 2008
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Med-El Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Locations

Country	Name	City	State
United States	Georgia Health Sciences University	Augusta	Georgia
United States	University of North Carolina-Chapel Hill/CCCDP	Durham	North Carolina
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fisseni HJ. (1998) Lehrbuch der psychologischen Diagnostik, Göttingen, Hogrefe.

Kühn-Inacker H, Weichbold V, Tsaikpini L, Coninx F, D'Hease P. (2003) LittlEARS Hörfragebogen - Handanweisung. MED-EL Headquarters, Innsbruck, Austria.

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. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the LittlEARS Auditory Questionnaire in hearing impaired children. The item analyses, scale analysis, analysis of expected values and minimal values have to be calculated, as it was performed with the US validation study.		24 months	No
Secondary	To determine if there are differences in statistical parameters between normal hearing children and hearing impaired children		24 months	No
Secondary	Longitudinal assessment of cochlear implanted children over 24 months after first CI fitting		24 months	No
Secondary	To establish the first words understood by a child with a cochlear implant		24 months	No
Secondary	To establish the first words spoken by a child with a cochlear implant		24 months	No
Secondary	To establish a sequence of word development		24 months	No
Secondary	To compare words and word categories in different languages		24 months	No