Peripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees

NCT ID: NCT05554692

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2027-03-31

Brief Summary

Older adults who use cochlear implants to address hearing loss show wide variation in benefit. This research investigates the role of normal aging, the health of peripheral and central auditory pathways, and positioning of the cochlear implant electrode array in contributing to this variability. A range of input types from simple auditory signals to spoken sentences is used to examine these questions.

Detailed Description

This research aims to understand age-related temporal processing in older cochlear-implant (CI) users. The overall objective is to disentangle the peripheral and central contributions to age-related temporal processing deficits in this population. The central hypothesis is that age-related speech perception deficits are explained by unique contributions from peripheral and central auditory functions, significantly affecting outcomes in older CI users.

The central hypothesis will be tested by determining (1) the extent to which temporal processing of simple signals from single-electrode stimulation can be explained by aging and the peripheral electrode-to-neural interface; (2) the extent to which speech perception can be explained by aging and the peripheral electrode-to-neural interface; (3) the extent and manner in which central auditory compensation overcomes peripheral processing deficits that contribute to age-related performance declines in CI subjects.

Outcome measures collected in this project include behavioral measures of speech and auditory perception and electrophysiological responses.

Also collected are questionnaire-based reports of history of CI device use, cognitive screening measures, and imaging-based information regarding electrode placement in the cochlea.

Better understanding of the locus of age-related temporal processing deficits in this population will aid in developing age-specific guidance regarding CI candidacy, programming, and rehabilitation, thereby improving expected benefit and quality of life.

Conditions

Hearing Loss; Cochlear Hearing Loss; Hearing Loss, Sensorineural; Aging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Enrolled Participants - Older adults with cochlear implants

Individuals who already use at least one cochlear implant.

Group Type: EXPERIMENTAL

Diagnostic tests of cochlear implant function

Intervention Type: DIAGNOSTIC_TEST

Because the subjects in the study will use CI devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of CI function. This will include perceptual tests of temporal discrimination and speech understanding.

Enrolled Participants - Adults with typical hearing

Control group to provide baseline or comparison data

Group Type: OTHER

Diagnostic tests of auditory function

Intervention Type: DIAGNOSTIC_TEST

The intervention here will be to carry out diagnostic tests of hearing. This will include perceptual tests of temporal discrimination and speech understanding.

Interventions

Diagnostic tests of cochlear implant function

Because the subjects in the study will use CI devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of CI function. This will include perceptual tests of temporal discrimination and speech understanding.

Intervention Type: DIAGNOSTIC_TEST

Diagnostic tests of auditory function

The intervention here will be to carry out diagnostic tests of hearing. This will include perceptual tests of temporal discrimination and speech understanding.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• cochlear implant in one or both ears
• post-lingual onset of deafness
• 1+ years cochlear implant experience
• use of Cochlear-brand implants
• implanted after 2004

• audiometrically normal hearing, near-normal hearing, or mild/moderate hearing loss.

Exclusion Criteria

• use of non-Cochlear-brand cochlear implants
• no use of oral language
• pregnant women are not eligible for the imaging portion of the study.
• residual acoustic hearing with unaided thresholds <90 dB HL at more than two standard audiometric frequencies
• other known disability or neurological disorder

For Typical Hearing arm:

• severe hearing loss
• history of neurological disorders
• history of middle-ear disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of Maryland, College Park

OTHER

Sponsor Role: lead

Responsible Party

Matthew Goupell

Professor, Department of Hearing and Speech Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J. Goupell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Samira B. Anderson, PhD

Role: STUDY_DIRECTOR

University of Maryland, College Park

Sandra Gordon-Salant, PhD

Role: STUDY_DIRECTOR

University of Maryland, College Park

Locations

University of Maryland, College Park

College Park, Maryland, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DC020316

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1781406

Identifier Type: -

Identifier Source: org_study_id