Comparing Site-selection Strategies

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

Comparing Site-selection Strategies for Improving Speech Recognition Outcomes

Several studies in the past have tried to deactivate electrodes that are less optimal to improve speech recognition outcomes. The study aims to compare the measures based on which the deactivation was performed. The investigators aim to first examine if the measures are strongly correlated each other, and then compare the deactivation effects across measures. These measures are mainly behavioral including electrode discrimination, amplitude modulation detection thresholds, low-rate and focused detection thresholds and electrode-modiolus distance. The endpoint of the study is speech recognition performance post deactivation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Department of Communication Sciences and Disorders, ECU

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

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

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children and adults with cochlear implants

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cochlear implant users with Nucleus and AB devices
Speech recognition will be evaluated after poor electrodes are turned off.
Behavioral: Site selection
Turning off electrodes on the electrode array based on imaging and psychophysical measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition with deactivation
Time Frame: 12 months post award notice and will take up to 3.5 years to complete
Electrodes will be evaluated based on (1) pitch discrimination (2) focused thresholds (3) amplitude modulation detection thresholds and (4) distances from the modious. Electrodes will be deactivated based on each of these measures and speech recognition will be evaluated to assess the effect of deactivation. The benefit of deactivation (speech recognition after deactivation minus before deactivation) will be derived for each measure. The measure that produces the greatest benefit will be identified.
12 months post award notice 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

Investigators

  • Principal Investigator: Ning Zhou, PHD, 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 (Actual)

August 1, 2020

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 12, 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_study4

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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