Littlears Auditory Questionnaire: Validation Study in CI Children (LittlEars)

April 10, 2017 updated by: Med-El Corporation

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Health Sciences University
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • University of North Carolina-Chapel Hill/CCCDP
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
cochlear implant
children less than 24 months at time of cochlear implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Validate the LittleEARS Auditory Questionnaire
Time Frame: 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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • Tsiakpini L, Weichbold V, Coninx F, D'Haese P (in print) Konstruktion eines Elternfragebogens zur Entwicklung des auditiven Verhaltens von Kleinkindern bis zu zwei Jahren.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (ESTIMATE)

November 5, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-EL NA 020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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