Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cochlear
ClinicalTrials.gov Identifier:
NCT01337076
First received: April 14, 2011
Last updated: September 18, 2014
Last verified: September 2014
Results First Received: September 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hearing Loss
Intervention: Device: cochlear implant

  Participant Flow
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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
Implanted Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation

Participant Flow:   Overall Study
    Implanted  
STARTED     21 [1]
COMPLETED     19 [2]
NOT COMPLETED     2  
[1] subjects implanted
[2] subjects met the primary endpoint of 6 months postimplant activation



  Baseline Characteristics
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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.
Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation.

Reporting Groups
  Description
Implanted Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation

Baseline Measures
    Implanted  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Mean ( Full Range )
  77  
  ( 32 to 88 )  
Gender  
[units: participants]
 
Female     4  
Male     17  
Study-Specific Measure [1]
[units: percent correct]
Mean ( Full Range )
  23.6  
  ( 12 to 35 )  
Study-Specific Measure [2]
[units: percent correct]
Mean ( Full Range )
  62.3  
  ( 47.2 to 86.4 )  
Study-Specific Measure [3]
[units: percent correct]
Mean ( Full Range )
  9.9  
  ( 0 to 34.8 )  
[1] Consonant Nucleus Consonant (CNC) Monosyllabic Word Test (Peterson & Lehiste, 1962). CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for words correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
[2] The Hearing in Noise Test (HINT) (Nilsson et al. 1994). The HINT sentences are recorded and consist of 25 equivalent lists. Each test list contains 10 sentences that vary from 3 to 7 words in length. Subjects will be tested in quiet using a configuration of speech at 0º azimuth in quiet.
[3] AzBio Sentence Test (Spahr & Dorman, 2005). The AzBio Test is a validated test that consists of 15 lists of 20 sentences each. Each list includes 5 sentences from each of 4 different male and female speakers. Each word in the sentence counts towards the overall score. Subjects will be tested using a configuration of speech and noise at 0º azimuth.



  Outcome Measures

1.  Primary:   CNC Monosyllabic Word Score - Treated Ear   [ Time Frame: Six months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Dr. Colin Driscoll
Organization: Mayo Clinic, Rochester
phone: 507 266 1965
e-mail: driscoll.colin@mayo.edu


No publications provided


Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT01337076     History of Changes
Other Study ID Numbers: CAM-EXP-A2010-01
Study First Received: April 14, 2011
Results First Received: September 18, 2014
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration