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

Mayo Clinic

Status: Completed

Conditions: Cochlear Implant

Treatments: Behavioral: NOOK; Behavioral: LACE

Study type: Interventional

Funder types: Other

Identifiers

NCT01737489

12-007641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

LACE ( Listening And Communication Enhancement )

Active Comparator group

Description:

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

Treatment:

Behavioral: LACE

NOOK (Electronic reader)

Active Comparator group

Description:

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

Treatment:

Behavioral: NOOK

Control

No Intervention group