Place-based Mapping in EAS Listeners

May 1, 2025 updated by: University of North Carolina, Chapel Hill

Place-based Mapping in Electric-acoustic Stimulation Listeners

Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps.

Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

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
      • Chapel Hill, North Carolina, United States, 27517
        • UNC ENT at Carolina Crossing

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Cochlear implant participants

Inclusion Criteria:

  • 18-80 years of age at implantation, identify English as native language, Medical Electronics (MED-EL) array recipient, and a postoperative unaided detection threshold of less than or equal to 65 decibel (dB) hearing level (HL) at 125 Hz

Exclusion Criteria:

  • Report or present with a cognitive delay or impairment

Normal-hearing controls

Inclusion Criteria:

  • 18-80 years of age at time of testing, unaided detection thresholds of 35 dB HL or better from 500-4000 Hz, identify English as native language

Exclusion Criteria:

  • Report or present with a cognitive delay or impairment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cochlear implant participants with Default maps
The default frequency filters assigned by the clinical software
Other: default mapping
Default frequency filter assignments
Experimental: Cochlear implant participants with Place-Based maps
Frequency filters adjusted to align with the cochlear place frequency
Other: place-based mapping
Adjusting the electric frequency filters to align with the cochlear place frequency
Other: Normal hearing controls listening to simulations
Normal hearing controls listening to simulations of default and place-based maps.
Other: default mapping
Default frequency filter assignments
Other: place-based mapping
Adjusting the electric frequency filters to align with the cochlear place frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time
Time Frame: Up to 12 months post-activation

Monaural perception (e.g., word recognition in quiet) will be assessed at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals.

This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).
Up to 12 months post-activation
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)
Time Frame: Up to 12 months post-activation

Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals.

This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).
Up to 12 months post-activation
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)
Time Frame: Up to 12 months post-activation

Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals.

This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).
Up to 12 months post-activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Abilities Over Time
Time Frame: Up to 12 months post-activation

Perceived abilities will be assessed with questionnaires (e.g., Speech, Spatial, and Qualities of hearing scale; SSQ) at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). A subject indicates his/her perceived abilities for each question on the SSQ using a Likert scale, with a range of 0-10 (with 10 indicating better perceived abilities). Responses will be compared between group over the study intervals.

This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).
Up to 12 months post-activation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing
Time Frame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

Participants with normal hearing (Arm 3) listening to simulations of default versus place-based maps.

All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no follow-up visits.
All procedures completed at baseline (one visit that was ~ 20 minutes in duration).
Vowel Recognition for Participants With Normal Hearing
Time Frame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

Vowel recognition for participants with normal hearing controls listening to simulations of default versus place-based maps.

All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits.
All procedures completed at baseline (one visit that was ~ 20 minutes in duration).
Sentence Understanding in Noise for Participants With Normal Hearing
Time Frame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

Sentence understanding in noise for participants with normal hearing controls listening to simulations of default versus place-based maps

All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits.
All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Margaret T Dillon, AuD, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Kevin D Brown, MD, PhD, University of North Carolina, Chapel Hill

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)

February 23, 2021

Primary Completion (Actual)

July 7, 2024

Study Completion (Actual)

July 7, 2024

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 20-3022
  • R21DC018389 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

beginning 9 to 36 months following publication

IPD Sharing Access Criteria

Investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

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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