The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss

August 14, 2023 updated by: University of Colorado, Denver

Age-related hearing loss, presbycusis, affects up to 50% of American adults. There are two main causes for presbycusis: 1) Progressive death of hair cells in the inner ear, and 2) Central hearing loss, or the reduced ability to decipher the sound source of interest from other competing sounds in a multi-source complex environment. The first cause is better understood and treatment options, such as hearing aids and cochlear implants, are available. However, central hearing loss is not as well understood and there is not a treatment available at this time. This study aims to advance our understanding of central hearing loss by evaluating the abilities of younger and older listeners in two primary outcome measures: to 1) neurologically process sound stimuli and 2) focus on conversational speech in the presence of spatially-separated competing background noise. A test using Auditory Brainstem Responses (ABR) will be used to evaluate the brain's response to clicking sounds.

This study will assess all waveform data, but will focus particularly on wave III. Sentence in noise tests will be used to assess each subject's ability to process speech in noisy situations. Both the ABR and sentence in noise tests are non-invasive and are commonly used in audiology practices to diagnosis and treat a variety of audiological pathologies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Locations

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

40 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

  1. Subjects age ranges

    a. 21 years (inclusive) and 89years (inclusive)

  2. Subjects exhibiting no poorer than a mild hearing loss, defined as hearing thresholds no worse than 40dBHL at any test frequency 250-4000 Hz based on pure tone audiometry
  3. Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)

Exclusion Criteria:

  1. Patients outside the age range of 21-89
  2. Patients with an air-bone gap greater than 10dBHL at any frequency
  3. Patients who are decisionally challenged and/or unable to complete speech perception testing. These patients are excluded based on the study requiring behavioral responses to some tests
  4. Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.
  5. Illiterate patients
  6. Patients with neurodegenerative diseases.

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: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech in Noise Performance
Time Frame: through study completion, an average of 6 years
Auditory perception task requiring participants to discriminate speech sound in quiet and in back ground noise. Takes about 90min.
through study completion, an average of 6 years
Auditory Brainstem Response
Time Frame: through study completion, an average of 6 years
Non-invasive auditory electrophysiological measure of brainstem electrical activity captured using electrodes placed on the scalp while sounds are played to one or both ears. Takes about 60min
through study completion, an average of 6 years
Spatial Acuity
Time Frame: through study completion, an average of 6 years
Auditory perception task requiring participants to judge the location of a sound. Takes about 90min
through study completion, an average of 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory Assessment
Time Frame: through study completion, an average of 6 years
Reading span test to understand working memory capacity. Takes about 20min
through study completion, an average of 6 years
Electrocorticogram
Time Frame: through study completion, an average of 6 years
Non-invasive auditory electrophysiological measure of brainstem electrical activity captured using electrodes placed on the scalp while sounds are played to one or both ears. Takes about 45min.
through study completion, an average of 6 years
Subject Questionnaires
Time Frame: through study completion, an average of 6 years
Questionnaires administered to subject to gather information on health and hearing history, noise exposure, everyday listening. Takes about 30min.
through study completion, an average of 6 years
TFS-AF
Time Frame: through study completion, an average of 6 years
Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 20min.
through study completion, an average of 6 years
Spectrotemporal Modulation
Time Frame: through study completion, an average of 6 years
Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 30min
through study completion, an average of 6 years

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Daniel Tollin, PhD, University of Colorado, Denver

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)

October 1, 2020

Primary Completion (Estimated)

May 29, 2026

Study Completion (Estimated)

May 29, 2026

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1213
  • R01DC017924 (U.S. NIH Grant/Contract)

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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