Auditory Perceptual DisordersNCT03475043
Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2
A study testing Auditory training: temporal cues in people with Auditory Perceptual Disorders and Aging Problems, run by University of Maryland, College Park at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Perceptual Disorders, Aging Problems
- What is being tested?
- Auditory training: temporal cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- absence of conductive hearing loss and middle-ear disease
- no neurological disease
- severe or profound hearing loss
- non-native speaker of English
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland
College Park, Maryland, 20742
About this study
Official title: Neuroplasticity in Auditory Aging_Auditory Temporal processing_Project 2
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.
- Conditions
- Auditory Perceptual Disorders, Aging Problems
- Being tested
- Auditory training: temporal cues
- Medical subject headings
- Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory training: temporal cuesBehavioural
Also called Auditory training: non-temporal cues
Behavioral training for 6-9 hours in listening to specific characteristics of acoustic signals. Listeners receive correct-answer feedback on each trial.
| Study group | Role | What they receive |
|---|---|---|
| Auditory training: temporal cues | Experimental | 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. Receives: Behavioral: Auditory training: temporal cues |
| Auditory training: non-temporal cues | Active comparator | 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. Receives: Behavioral: Auditory training: temporal cues |
| Passive control group (Aims 1 and 2) | No intervention | Listeners will be evaluated on pre-training and post-training tests, but will receive no training at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: completion of study, approximately 30 months
Improvement in recognition of trained stimuli - fast speech (Aim 2)
Increase in speech rate at which listener maintains 50% and 80% correct recognition
Measured: completion of study, approximately 24 months
Secondary outcomes (3)
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
Measured: completion of study, approximately 30 months
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
Measured: completion of study in approximately 24 months
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
Measured: completion of study in approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start21 Feb 2018
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Perceptual DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group Active control group Passive control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Sandra Gordon Salant, University of Maryland, College Park
- Investigators
- Sandra Gordon-Salant, Ph.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475043
- Sponsor's protocol ID
- UMDCP_P01P2
- Other IDs
- P01AG055365
- Status last verified
- Apr 2025
- First submitted
- 15 Mar 2018
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity in Auditory Aging_Auditory Temporal processing_Project 2
- ClinicalTrials.gov ID
- NCT03475043
- Acronym / sponsor ID
- UMDCP_P01P2
- Conditions
- Auditory Perceptual Disorders, Aging Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Experimental group Active control group Passive control group
| Arm | Type | Receives |
|---|---|---|
| Auditory training: temporal cues | Experimental | Behavioral: Auditory training: temporal cuesAim 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. |
| Auditory training: non-temporal cues | Active comparator | Behavioral: Auditory training: temporal cuesAim 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. |
| Passive control group (Aims 1 and 2) | No intervention | –Listeners will be evaluated on pre-training and post-training tests, but will receive no training at all. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- absence of conductive hearing loss and middle-ear disease
- no neurological disease
- severe or profound hearing loss
- non-native speaker of English
- cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory training: temporal cuesAlso: Auditory training: non-temporal cuesBehavioral training for 6-9 hours in listening to specific characteristics of acoustic signals. Listeners receive correct-answer feedback on each trial. | Behavioural | Auditory training: non-temporal cues, Auditory training: temporal cues |
Primary outcome
Improvement in behavioral auditory temporal processing measures (Aim 1)
Time frame: completion of study, approximately 30 months
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
Improvement in recognition of trained stimuli - fast speech (Aim 2)
Time frame: completion of study, approximately 24 months
Increase in speech rate at which listener maintains 50% and 80% correct recognition
3 secondary outcomes
Change in spectral energy and neural phase locking for trained stimuli (Aim 1)
Time frame: completion of study, approximately 30 months
Change in phase locking to trained or equivalent stimuli (Aim 2)
Time frame: completion of study in approximately 24 months
Change in reconstruction accuracy to trained or equivalent stimuli (Aim 2)
Time frame: completion of study in approximately 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: 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.
Related trials for Auditory Perceptual Disorders
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Not yet recruiting
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
Recruiting
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Schizophrenia, Hallucinations, Auditory
Not yet recruitingObservational study
Building a Computational Model of Auditory Hallucinations
Schizophrenia / Schizoaffective Disorder, Schizophrenia and Disorders With Psychotic Feature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Gordon-Salant, Ph.D. principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory training: temporal cues in people with Auditory Perceptual Disorders and Aging Problems, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in behavioral auditory temporal processing measures (Aim 1) (time frame: completion of study, approximately 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.