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OpenTrials
Completed

NCT Number: NCT01737489

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.

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Key information

Conditions

Cochlear Implant

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LACE

Behavioral

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

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.

Primary outcomes

  1. 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.

  2. 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

  1. Percent of speech comprehension

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 29, 2012
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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