Clinical trial NCT04513782: The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss
Official title: The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Individuals
Hearing Loss, Central
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2020-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Speech in Noise Performance
timeFrame: through study completion, an average of 6 years
measure: Auditory Brainstem Response
timeFrame: through study completion, an average of 6 years
measure: Spatial Acuity
timeFrame: through study completion, an average of 6 years
Secondary outcomes:
measure: Working Memory Assessment
timeFrame: through study completion, an average of 6 years
measure: Electrocorticogram
timeFrame: through study completion, an average of 6 years
measure: Subject Questionnaires
timeFrame: through study completion, an average of 6 years
measure: TFS-AF
timeFrame: through study completion, an average of 6 years
measure: Spectrotemporal Modulation
timeFrame: through study completion, an average of 6 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Daniel Tollin, PhD
role: PRINCIPAL_INVESTIGATOR
References: