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

NCT04513782 | Recruiting

• 2 other identifiers: 19-1213R01DC017924
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Individuals; Hearing Loss, Central

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Working Memory Assessment

  through study completion, an average of 6 years

• Electrocorticogram

  through study completion, an average of 6 years

• Subject Questionnaires

  through study completion, an average of 6 years

• TFS-AF

  through study completion, an average of 6 years

• Spectrotemporal Modulation

  through study completion, an average of 6 years

Interventions

Audiological Assessments DIAGNOSTIC_TEST

Participants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss.

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• Subjects age ranges
• a. 21 years (inclusive) and 89years (inclusive)
• 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
• Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)

You may not qualify if:

• Patients outside the age range of 21-89
• Patients with an air-bone gap greater than 10dBHL at any frequency
• 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
• Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.
• Illiterate patients
• Patients with neurodegenerative diseases.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Central

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Auditory Diseases, Central; Retrocochlear Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Tollin, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaylene Denham

CONTACT

303-724-8465; shaylene.denham@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 14, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)