- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01059838
Speech Perception for Children With Cochlear Implants
Speech Perception in Noise for Children With Cochlear Implants
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: single subject
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testing the ability for sentence recognition in quiet and in noise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cynthia A Hargenrader, PhD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-005368
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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