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Clinical Trials/NCT01737489
NCT01737489CompletedNot Applicable

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

Mayo Clinic1 site in 1 country17 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
Word recognition

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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.

Arms & Interventions

Control

No Intervention

LACE ( Listening And Communication Enhancement )

Active Comparator

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

Intervention: LACE (Behavioral)

NOOK (Electronic reader)

Active Comparator

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

Intervention: NOOK (Behavioral)

Outcomes

Primary Outcomes

Word recognition

Time Frame: 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

Time Frame: baseline to 6 months

The signal to noise ratio will be measured using the Bamford-Kowal-Bench (BKB) test.

Secondary Outcomes

  • Percent of speech comprehension(baseline to 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Annamary (Ann) Peterson

AUDIOLOGIST

Mayo Clinic

Study Sites (1)

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