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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03475043
Other study ID # UMDCP_P01P2
Secondary ID P01AG055365
Status Recruiting
Phase N/A
First received
Last updated
Start date February 21, 2018
Est. completion date May 31, 2024

Study information

Verified date November 2023
Source University of Maryland, College Park
Contact Sandra Gordon-Salant, Ph.D.
Phone 3014054225
Email sgsalant@umd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Millions of elderly adults in the USA have age related hearing loss (ARHL), a malady that affects half of adults 60-69 years, and the majority of older adults. This hearing loss not only impacts communication and functional ability, but also is strongly associated with cognitive decline and decreased quality of life. This project aims to develop effective strategies to compensate and reverse this process through a deeper understanding of plasticity and adaptive auditory function, and how to engage it and harness it to remedy ARHL.


Description:

The detrimental effects of aging on auditory temporal processing have been well documented in humans and animal models. At present, there are gaps in knowledge of the extent to which these auditory temporal processing deficits can be mitigated in older adults with or without hearing loss through auditory training and neuroplasticity, to improve precision of neural timing and speech understanding. The long-term goal is to determine the extent to which hearing deficits in older adults can be ameliorated with auditory training. The investigators propose an innovative approach to the investigation of aging, hearing, and neuroplasticity by marrying perceptual training experiments with electrophysiological measurements. The objectives are to compare young normal-hearing (YNH), older normal-hearing (ONH), and older hearing-impaired (OHI) adult listeners, and evaluate the improvements in perceptual and electrophysiological measures of temporal processing after explicit training on auditory temporal processing tasks. The central hypothesis is that training of auditory temporal processing will produce concomitant improvements in both perceptual performance and neural encoding, which will close the gap in the age-related differences between groups. The central hypothesis will be tested by pursuing two specific aims: (Aim 1) Determine the extent to which perceptual training on temporal rate discrimination using simple non-speech stimuli improves perceptual and neural encoding in YNH, ONH, and OHI listeners; and (Aim 2) Determine the extent to which perceptual training on the processing of sentences with increasing presentation rate can improve behavioral performance and neural encoding in YNH, ONH, and OHI listeners. The expected outcomes are that the investigators will learn what perceptual training tasks lead to simultaneous improvements in perceptual and neural auditory temporal processing and the findings will produce a significant impact in older listeners who experience difficulty in communicating in daily life because they will lead directly to focused and novel forms of rehabilitation. This research is innovative because the investigators will have established techniques that are proven to provide significant improvements in auditory temporal processing and speech perception, combined with evidence of improvements to neural encoding. These studies will serve the larger goals of the program project grant because they will help identify the neuroplastic mechanisms in the brain of humans that correspond to successful behavioral outcomes in younger and older adults.


Recruitment information / eligibility

Status Recruiting
Enrollment 405
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - native speaker of English - normal cognitive function as measured on Montreal Cognitive Assessment - pass screening auditory brainstem response test to make sure they have recordable brainwaves to acoustic stimuli - age and hearing sensitivity: - young normal-hearing listeners, 18-35 years, hearing thresholds less than 25 decibels (dB) HL from 250 - 4000 Hz; - older normal-hearing listeners, 65-85 years, hearing thresholds less than 25 dB HL, from 250-4000 Hz; - older hearing-impaired listeners, 65-85 years, with mild-to-moderate, high frequency sensorineural hearing loss; - high school diploma Exclusion Criteria: - absence of conductive hearing loss and middle-ear disease - no neurological disease - severe or profound hearing loss - non-native speaker of English - cognitive impairment

Study Design


Intervention

Behavioral:
Auditory training: temporal cues
Behavioral training for 6-9 hours in listening to specific characteristics of acoustic signals. Listeners receive correct-answer feedback on each trial.

Locations

Country Name City State
United States University of Maryland College Park Maryland

Sponsors (3)

Lead Sponsor Collaborator
University of Maryland, College Park National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in behavioral auditory temporal processing measures (Aim 1) Decrease in threshold (in msec) for discriminating a comparison pulse train to a standard, decrease in cross-over points (in msec) for trained word contrasts, and increase in rate of speech for 50% correct recognition completion of study, approximately 30 months
Primary Improvement in recognition of trained stimuli - fast speech (Aim 2) Increase in speech rate at which listener maintains 50% and 80% correct recognition completion of study, approximately 24 months
Secondary Change in spectral energy and neural phase locking for trained stimuli (Aim 1) Increase in spectral energy for pulse trains, cessation of neural phase locking for trained words during silent intervals of the word, and increase in phase-locking factor following training of time-compressed speech, as measured on the Auditory Steady-State Response completion of study, approximately 30 months
Secondary Change in phase locking to trained or equivalent stimuli (Aim 2) Increase in phase-locking factor following training of time-compressed speech, as measured in the frequency-following response completion of study in approximately 24 months
Secondary Change in reconstruction accuracy to trained or equivalent stimuli (Aim 2) Increase in reconstruction accuracy following training of time-compressed speech, as measured with envelope tracking to five-minute speech samples completion of study in approximately 24 months
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