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

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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 Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hearing Loss
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cochlear Implant
Hide Arm/Group Description children less than 24 months at time of cochlear implantation
Period Title: Overall Study
Started 31
Completed 24
Not Completed 7
Reason Not Completed
Lost to Follow-up             7
Arm/Group Title Cochlear Implant
Hide Arm/Group Description children less than 24 months at time of cochlear implantation
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 31 participants
16.2
(11.1 to 24.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
19
  61.3%
Male
12
  38.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title To Validate the LittleEARS Auditory Questionnaire
Hide Description 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.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cochlear Implant
Hide Arm/Group Description:
children less than 24 months at time of cochlear implantation
Overall Number of Participants Analyzed 24
Mean (Full Range)
Unit of Measure: units on a scale
34.75
(33 to 35)
2.Secondary Outcome
Title Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting
Hide Description 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.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cochlear Implant
Hide Arm/Group Description:
children less than 24 months at time of cochlear implantation
Overall Number of Participants Analyzed 24
Mean (Full Range)
Unit of Measure: units on a scale
28.78
(10 to 35)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cochlear Implant
Hide Arm/Group Description children less than 24 months at time of cochlear implantation
All-Cause Mortality
Cochlear Implant
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cochlear Implant
Affected / at Risk (%)
Total   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cochlear Implant
Affected / at Risk (%)
Total   0/31 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sr. Clinical Research Associate
Organization: MED-EL Corporation
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.
Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT00785707     History of Changes
Other Study ID Numbers: MED-EL NA 020
First Submitted: November 4, 2008
First Posted: November 5, 2008
Results First Submitted: February 17, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017