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Speech Perception for Children With Cochlear Implants

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sentence recognition
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Loss focused on measuring pediatrics, cochlear implant

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children with bilateral sensorineural hearing loss who have 1) one or two Nucleus 24 series cochlear implants, 2) at least 1 year experience with their cochlear implant, and, 3) the ability to score > 50% correct for HINT sentences in quiet.

Exclusion Criteria: 1) Patients under 4 years of age or over 17 years of age, 2) patients who have had at least 1 year experience with their cochlear implant and, 3) patients who score > 50% for HINT sentence recognition in quiet

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single subject

Arm Description

Outcomes

Primary Outcome Measures

The Objective is to examine speech perception performance in the presence of restaurant noise for pediatric cochlear implant recipients in two listening conditions: ADRO alone & ASC + ADRO.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2010
Last Updated
September 7, 2017
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01059838
Brief Title
Speech Perception for Children With Cochlear Implants
Official Title
Speech Perception in Noise for Children With Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an ASC program.
Detailed Description
The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an ASC program. You will be asked to listen to sentences in quiet and in noise and repeat the sentences. You will be seated in a comfortable chair inside the sound booth with 8 loudspeakers placed in a circular pattern around your head. We will test your sentence recognition abilities in your listening program as well as in the new listening program. The sentences and noise will be presented through loudspeakers at levels typically encountered in everyday communication environments. Your participation would involve approximately 20 minutes of testing plus 10 minutes to add the new listening program to their processor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
pediatrics, cochlear implant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single subject
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
sentence recognition
Intervention Description
testing the ability for sentence recognition in quiet and in noise.
Primary Outcome Measure Information:
Title
The Objective is to examine speech perception performance in the presence of restaurant noise for pediatric cochlear implant recipients in two listening conditions: ADRO alone & ASC + ADRO.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with bilateral sensorineural hearing loss who have 1) one or two Nucleus 24 series cochlear implants, 2) at least 1 year experience with their cochlear implant, and, 3) the ability to score > 50% correct for HINT sentences in quiet. Exclusion Criteria: 1) Patients under 4 years of age or over 17 years of age, 2) patients who have had at least 1 year experience with their cochlear implant and, 3) patients who score > 50% for HINT sentence recognition in quiet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia A Hargenrader, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Speech Perception for Children With Cochlear Implants

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