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

NCT01737489 | Completed

• 1 other identifier: 12-007641
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Percent of speech comprehension

  baseline to 6 months

Study Arms (3)

LACE ( Listening And Communication Enhancement )

ACTIVE COMPARATOR

use the commercially available auditory training program which is administered by computer as daily lessons.

Behavioral: LACE

NOOK (Electronic reader)

ACTIVE COMPARATOR

will use an electronic reader (NOOK device) to do speech tracking

Behavioral: NOOK

Control

NO INTERVENTION

Interventions

LACE BEHAVIORAL

commercially available LACE program which is administered by computer as daily lessons. The participants will do this program for one month

LACE ( Listening And Communication Enhancement )

NOOK BEHAVIORAL

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.

NOOK (Electronic reader)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Annamary Peterson

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AUDIOLOGIST

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

US (1)