Auditory Training With Speech Related Acoustic Cues Using Psychophysical Testing

April 6, 2023 updated by: Heather Wright, East Carolina University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cochlear implant users
The group will receive auditory training (psychophysical), and will be evaluated for speech recognition to determine the effect of training.
Behavioral: Auditory training
Training with psychophysical tests (amplitude modulation detection on single electrodes) for improving speech recognition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech recognition after training
Time Frame: starting 12 months after the award and will take up to 3.5 years to complete
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 Finally, the subjects will be measured for speech recognition the third time after the training is withdrawn following a ABA longitudinal design.
starting 12 months after the award and will take up to 3.5 years to complete

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 26, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhou_R01_study5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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