Title: Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods

Study Overview
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Brief Summary
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The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

Detailed Description
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The primary objective of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. The secondary objective of this study is to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

Official Title
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Title: Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods

Conditions
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Cochlear Implant

Intervention / Treatment
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* Behavioral: LACE
* Behavioral: NOOK


Participation Criteria
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Eligibility Criteria
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Criteria for Inclusion: Willingness to participate Ability to provide informed written consent Willingness to follow study protocol Eighteen years or older at the time of signing the consent form Cochlear implant experience for 12 months or greater Spoken English as the first language Access to a home computer which meets the minimal requirements to run appropriate program or the ability to use an electronic reader depending on which group the participant is assigned to. Reports being comfortable using a computer if in the LACE group Criteria for Exclusion: Unable or unwillingness to sign informed written consent Unable or unwillingness to follow study protocol Non-English speaking or English as a second language No access to a computer if assigned to the LACE study group Reports not being comfortable using a computer if assigned to the LACE study group.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LACE ( Listening And Communication Enhancement )<br>use the commercially available auditory training program which is administered by computer as daily lessons. | Behavioral: LACE<br>* commercially available LACE program which is administered by computer as daily lessons. The participants will do this program for one month<br>|
| Active Comparator: NOOK (Electronic reader)<br>will use an electronic reader (NOOK device) to do speech tracking | Behavioral: NOOK<br>* will use an electronic reader (Barnes and Noble - NOOK device) to do speech tracking.will do this activity for approximately one hour per day for five days out of seven for a total of four weeks. The speech tracking activity will involve reading approximately two books within the one month time frame. The participants will listen to the book while reading an unabridged book in printed form.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word recognition | Word recognition will be measured using the Consonant Nucleus Consonant (CNC) Test, a 50 word open set test. | baseline to 6 months | 
| Signal-to-noise ratio | The signal to noise ratio will be measured using the Bamford-Kowal-Bench (BKB) test. | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of speech comprehension | Percent of speech comprehension will be measured by the AzBio Sentence Lists, which were created at Arizona State University and evaluate speech understanding. | baseline to 6 months |