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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Annamary (Ann) Peterson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01737489
First received: November 27, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cochlear Implant
Behavioral: LACE
Behavioral: NOOK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Word recognition [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The signal to noise ratio will be measured using the Bamford-Kowal-Bench (BKB) test.


Secondary Outcome Measures:
  • Percent of speech comprehension [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
    Percent of speech comprehension will be measured by the AzBio Sentence Lists, which were created at Arizona State University and evaluate speech understanding.


Estimated Enrollment: 21
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737489

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Annamary Peterson Mayo Clinic
  More Information

No publications provided

Responsible Party: Annamary (Ann) Peterson, AUDIOLOGIST, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01737489     History of Changes
Other Study ID Numbers: 12-007641
Study First Received: November 27, 2012
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014