Littlears Auditory Questionnaire: Validation Study in CI Children - Full Text View

Sponsored by:	Med-El Corporation
Information provided by:	Med-El Corporation
ClinicalTrials.gov Identifier:	NCT00785707

Purpose

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.

Condition
Hearing Loss

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Littlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English

Further study details as provided by Med-El Corporation:

Primary Outcome Measures:

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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if there are differences in statistical parameters between normal hearing children and hearing impaired children [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Longitudinal assessment of cochlear implanted children over 24 months after first CI fitting [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To establish the first words understood by a child with a cochlear implant [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To establish the first words spoken by a child with a cochlear implant [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To establish a sequence of word development [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To compare words and word categories in different languages [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
cochlear implant children less than 24 months at time of cochlear implantation

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785707

Locations

United States, Texas
Cook Children's Medical Center	Recruiting
Fort Worth, Texas, United States, 76104
Contact: Becky Clem, MA 682-885-4063 beckyc@cookchildrens.org
Principal Investigator: Becky Clem, MA
Sub-Investigator: Tracy Burger, MS
Sub-Investigator: Allison Haggerty, MS
Sub-Investigator: Jennifer McReynolds, MS
Sub-Investigator: Jennifer McReynolds, MS
Sub-Investigator: Bari Pham, AuD
United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Christina Runge-Samuelson, PhD 414-805-5586 crunge@mcw.edu
Sub-Investigator: Jamie Jensen, MS
Principal Investigator: Christina Runge-Samuelson, PhD
Sub-Investigator: Linda Burg, MS
Sub-Investigator: Sarah Drake, MS
Sub-Investigator: Karla Balko, MS

Sponsors and Collaborators

Med-El Corporation

More Information

Responsible Party:	MED-EL Corporation ( Richard Collette, CEO )
Study ID Numbers:	MED-EL NA 020
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00785707
Health Authority:	United States: Institutional Review Board

Keywords provided by Med-El Corporation:

sensorineural hearing loss
cochlear implant

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases

Sensorineural hearing loss
Neurologic Manifestations
Hearing Loss, Sensorineural
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009