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

Not Applicable

Completed

• Conditions: Cochlear Implant
• Interventions: Behavioral: LACE; Behavioral: NOOK

• Registration Number: NCT01737489
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LACE ( Listening And Communication Enhancement )	LACE	use the commercially available auditory training program which is administered by computer as daily lessons.
NOOK (Electronic reader)	NOOK	will use an electronic reader (NOOK device) to do speech tracking

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent of speech comprehension	baseline to 6 months	Percent of speech comprehension will be measured by the AzBio Sentence Lists, which were created at Arizona State University and evaluate speech understanding.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States