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CompletedNCT03475043Updated Apr 8, 2025

Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2

An interventional study of Auditory training: temporal cues in Auditory Perceptual Disorders and Aging Problems, sponsored by University of Maryland, College Park. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
405
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed 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.

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Conditions studied

  • Auditory Perceptual Disorders
  • Aging Problems
03

In context

Auditory Perceptual Disorders

24 studies on the registry are indexed under Auditory Perceptual Disorders; 3 are open to participants now.

This study's enrollment of 405 is above the median of 52 across 18 interventional studies indexed under Auditory Perceptual Disorders.

Browse Auditory Perceptual Disorders studies →

Lead sponsor

University of Maryland, College Park is the lead sponsor of 62 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • native speaker of English
  • normal cognitive function as measured on
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
405 participants (actual)

Study arms

  • Experimental
    Auditory training: temporal cues

    Aim 1: Listeners will hear target acoustic stimuli that vary in a temporal (timing/duration) cue for 9, 1-hour training sessions and will receive correct-answer feedback. Aim 2: Listeners will hear sentences that vary in speech rate for 6, 1-hour training sessions and will receive correct-answer feedback.

    Behavioral: Auditory training: temporal cues

  • Active comparator
    Auditory training: non-temporal cues

    Aim 1: Listeners will hear target acoustic stimuli that vary in either stimulus intensity or stimulus frequency during 9, 1-hour training sessions and will receive correct-answer feedback. Aim 2: Listeners will hear speech in varying levels of noise during 6, 1-hour training sessions and will receive correct-answer feedback.

    Behavioral: Auditory training: temporal cues

  • No intervention
    Passive control group (Aims 1 and 2)

    Listeners will be evaluated on pre-training and post-training tests, but will receive no training at all.

Interventions

  • BehavioralAuditory 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.

    Also known as: Auditory training: non-temporal cues

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: completion of study, approximately 30 months

  2. Improvement in recognition of trained stimuli - fast speech (Aim 2)

    Increase in speech rate at which listener maintains 50% and 80% correct recognition

    Time frame: completion of study, approximately 24 months

Secondary outcomes

  1. 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

    Time frame: completion of study, approximately 30 months

  2. 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

    Time frame: completion of study in approximately 24 months

  3. 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

    Time frame: completion of study in approximately 24 months

07

Study locations

1 site
  • University of Maryland
    College Park, Maryland 20742, United States
08

References and documents

Individual participant data

Plan to share: Yes — The investigators will share the final dataset that includes initial assessment information, behavioral performance pre-training and post-training data, and neurophysiologic data. Any shared dataset(s) will be stripped of protected health information (PHI) before release, and the investigators will make the data and associated documentation available only to IRB-approved colleagues and collaborators under an agreement that provides for: (1) a commitment to using the data only for research purposes and not to inappropriately identify any individual participant; and (2) a commitment to securing the data using appropriate information technology and practices.

Supporting information: Study protocol

Time frame: Six months after publication until May 31, 2022

Access criteria: The data will be available only to Institutional Review Board-approved colleagues and collaborators under an agreement that provides for: (1) a commitment to using the data only for research purposes and not to inappropriately identify any individual participant; and (2) a commitment to securing the data using appropriate information technology and practices. The PI (Gordon-Salant) and co-PI (Anderson) will review requests for access to the data. Once approved, access will be provided by Prometheus Software, LLC. Prometheus will develop best practices for securely sharing research data with our collaborators and the wider scientific community. Finally, Prometheus will ensure that the project complies with all relevant data distribution agreements and data submission requirements.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in May 2024, 75 months.

Of 12 interventional studies with no phase under Auditory Perceptual Disorders, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 62. This study's 75 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2018
First posted
Mar 23, 2018
StartActual
Feb 21, 2018
Primary completionActual
May 31, 2024
CompletionActual
May 31, 2024
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03475043
Lead sponsor
University of Maryland, College Park
Responsible party
Sandra Gordon Salant (Professor, University of Maryland, College Park) — Principal investigator
First posted
Mar 23, 2018
Start date
Feb 21, 2018
Primary completion
May 31, 2024
Completion
May 31, 2024
Last update
Apr 8, 2025

Study contacts

Sandra Gordon-Salant, Ph.D.
principal investigator · University of Maryland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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