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

Cochlear Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737489
• Other study ID #: 12-007641
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: September 7, 2017
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Word recognition	Word recognition will be measured using the Consonant Nucleus Consonant (CNC) Test, a 50 word open set test.	baseline to 6 months
Primary	Signal-to-noise ratio	The signal to noise ratio will be measured using the Bamford-Kowal-Bench (BKB) test.	baseline to 6 months
Secondary	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