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

Healthy Individuals Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513782
• Other study ID #: 19-1213
• Secondary ID: R01DC017924
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: May 29, 2026

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: Shaylene Denham
• Phone: 303-724-8465
• Email: shaylene.denham[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 29, 2026
• Est. primary completion date: May 29, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Healthy Individuals
• Hearing Loss
• Hearing Loss, Central

Intervention

Diagnostic Test:
• Audiological Assessments
Participants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss.

Locations

Country	Name	City	State
United States	University of Colorado School of Medicine	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech in Noise Performance	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
Primary	Auditory Brainstem Response	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
Primary	Spatial Acuity	Auditory perception task requiring participants to judge the location of a sound. Takes about 90min	through study completion, an average of 6 years
Secondary	Working Memory Assessment	Reading span test to understand working memory capacity. Takes about 20min	through study completion, an average of 6 years
Secondary	Electrocorticogram	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
Secondary	Subject Questionnaires	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
Secondary	TFS-AF	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
Secondary	Spectrotemporal Modulation	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