NCT00785707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

April 1, 2017

Enrollment Period

7.8 years

First QC Date

November 4, 2008

Results QC Date

February 17, 2017

Last Update Submit

April 10, 2017

Conditions

Hearing Loss

Keywords

sensorineural hearing losscochlear implant

Outcome Measures

Primary Outcomes (1)

  • To Validate the LittleEARS Auditory Questionnaire

    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 Outcomes (1)

  • Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting

    24 months

Study Arms (1)

cochlear implant

children less than 24 months at time of cochlear implantation

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children under the age of 24 months at time of cochlear implantation recommended by the cochlear implant clinic.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

University of North Carolina-Chapel Hill/CCCDP

Durham, North Carolina, 27713, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

  • Fisseni HJ. (1998) Lehrbuch der psychologischen Diagnostik, Göttingen, Hogrefe.

    BACKGROUND

  • Kühn-Inacker H, Weichbold V, Tsaikpini L, Coninx F, D'Hease P. (2003) LittlEARS Hörfragebogen - Handanweisung. MED-EL Headquarters, Innsbruck, Austria.

    BACKGROUND

  • Weichbold V, Tsiakpini L, Coninx F, D'Haese P. [Development of a parent questionnaire for assessment of auditory behaviour of infants up to two years of age]. Laryngorhinootologie. 2005 May;84(5):328-34. doi: 10.1055/s-2004-826232. German.

    PMID: 15909244BACKGROUND

MeSH Terms

Conditions

Hearing LossHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sr. Clinical Research Associate
Organization
MED-EL Corporation
clinicaltrials@medelus.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

May 1, 2008

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 26, 2017

Results First Posted

June 26, 2017

Record last verified: 2017-04

Locations

US(5)