Littlears Auditory Questionnaire: Validation Study in CI Children

Completed

• Conditions: Hearing Loss

• Registration Number: NCT00785707
• Lead Sponsor: Med-El Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-02-17
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Results First Posted: 2017-06-26
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Validate the LittleEARS Auditory Questionnaire	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting	24 months	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.

Trial Locations

Locations (5)

Georgia Health Sciences University; 🇺🇸 Augusta, Georgia, United States

University of North Carolina-Chapel Hill/CCCDP; 🇺🇸 Durham, North Carolina, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Cook Children's Medical Center; 🇺🇸 Fort Worth, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States