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

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.

Study Overview

• Status: Completed
• Conditions: Cochlear Implant
• Intervention / Treatment: Behavioral: LACE; Behavioral: NOOK

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: LACE ( Listening And Communication Enhancement ); use the commercially available auditory training program which is administered by computer as daily lessons.	Behavioral: LACE; commercially available LACE program which is administered by computer as daily lessons. The participants will do this program for one month
Active Comparator: NOOK (Electronic reader); will use an electronic reader (NOOK device) to do speech tracking	Behavioral: NOOK; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Annamary Peterson, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 12-007641