Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00785707
Recruitment Status : Completed
First Posted : November 5, 2008
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Hearing Loss

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Littlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English
Study Start Date : May 2008
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785707


Locations
Layout table for location information
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, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Layout table for additonal information
Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT00785707    
Other Study ID Numbers: MED-EL NA 020
First Posted: November 5, 2008    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: April 2017
Keywords provided by Med-El Corporation:
sensorineural hearing loss
cochlear implant
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases