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

NCT ID: NCT01737489

Last Updated: 2017-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Cochlear Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LACE ( Listening And Communication Enhancement )

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

Group Type ACTIVE_COMPARATOR

LACE

Intervention Type BEHAVIORAL

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

NOOK (Electronic reader)

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

Group Type ACTIVE_COMPARATOR

NOOK

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LACE

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Annamary (Ann) Peterson

AUDIOLOGIST

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annamary Peterson

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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12-007641

Identifier Type: -

Identifier Source: org_study_id

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