Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation
ClinicalTrials.gov Identifier:
NCT00785707
First received: November 4, 2008
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
United States, North Carolina
University of North Carolina-Chapel Hill/CCCDP
Durham, North Carolina, United States, 27713
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Med-El Corporation
  More Information

No publications provided

Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT00785707     History of Changes
Other Study ID Numbers: MED-EL NA 020
Study First Received: November 4, 2008
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Med-El Corporation:
sensorineural hearing loss
cochlear implant

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013