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Auditory Training With Speech Related Acoustic Cues Using Psychophysical Testing

Primary Purpose

Deafness

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auditory training
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Deafness

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Native speakers of English
  • Cochlear Nucleus cochlear implant users or Advanced Bionics users
  • Postlingually deafened
  • Has had device experience for at least one year
  • Can be child or adult at the time of enrollment

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cochlear implant users

    Arm Description

    The group will receive auditory training (psychophysical), and will be evaluated for speech recognition to determine the effect of training.

    Outcomes

    Primary Outcome Measures

    speech recognition after training
    Subjects will be measured for their baseline speech recognition performance (A) and then measured again for speech recognition after receiving auditory training using the psychophysical methods (B). Finally, the subjects will be measured for speech recognition the third time after the training is withdrawn following a ABA longitudinal design.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 5, 2019
    Last Updated
    April 6, 2023
    Sponsor
    East Carolina University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03867032
    Brief Title
    Auditory Training With Speech Related Acoustic Cues Using Psychophysical Testing
    Official Title
    Auditory Training With Speech Related Acoustic Cues Using Psychophysical Testing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI passed away. Ending grant and closing down lab
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    December 26, 2022 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    East Carolina University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study, the investigators will evaluate whether auditory training with speech-related acoustic features in psychophysical testing will help CI subjects improve speech recognition. The primary endpoint is the speech recognition measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deafness

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cochlear implant users
    Arm Type
    Experimental
    Arm Description
    The group will receive auditory training (psychophysical), and will be evaluated for speech recognition to determine the effect of training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Auditory training
    Intervention Description
    Training with psychophysical tests (amplitude modulation detection on single electrodes) for improving speech recognition
    Primary Outcome Measure Information:
    Title
    speech recognition after training
    Description
    Subjects will be measured for their baseline speech recognition performance (A) and then measured again for speech recognition after receiving auditory training using the psychophysical methods (B). Finally, the subjects will be measured for speech recognition the third time after the training is withdrawn following a ABA longitudinal design.
    Time Frame
    starting 12 months after the award and will take up to 3.5 years to complete

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Native speakers of English Cochlear Nucleus cochlear implant users or Advanced Bionics users Postlingually deafened Has had device experience for at least one year Can be child or adult at the time of enrollment Exclusion Criteria: None

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    19293398
    Citation
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