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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cochlear Implant children less than 24 months at time of cochlear implantation

Participant Flow:   Overall Study
    Cochlear Implant
STARTED   31 
COMPLETED   24 
NOT COMPLETED   7 
Lost to Follow-up                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cochlear Implant children less than 24 months at time of cochlear implantation

Baseline Measures
   Cochlear Implant 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Months]
Mean (Full Range)
 
Participants Analyzed   31 
   16.2 
 (11.1 to 24.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   31 
Female      19  61.3% 
Male      12  38.7% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   31 
United States   31 


  Outcome Measures

1.  Primary:   To Validate the LittleEARS Auditory Questionnaire   [ Time Frame: 24 months ]

2.  Secondary:   Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: clinicaltrials@medelus.com


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