search
Back to results

Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2

Primary Purpose

Auditory Perceptual Disorders, Aging Problems

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory training: temporal cues
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Auditory Perceptual Disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of MarylandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Auditory training: temporal cues

Auditory training: non-temporal cues

Passive control group (Aims 1 and 2)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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
Improvement in recognition of trained stimuli - fast speech (Aim 2)
Increase in speech rate at which listener maintains 50% and 80% correct recognition

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 15, 2018
Last Updated
May 9, 2023
Sponsor
University of Maryland, College Park
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT03475043
Brief Title
Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2
Official Title
Neuroplasticity in Auditory Aging_Auditory Temporal processing_Project 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, College Park
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Perceptual Disorders, Aging Problems

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group Active control group Passive control group
Masking
Outcomes Assessor
Masking Description
Examiners who conduct pre, post, and retention tests with participants do not know to which group a participant is assigned (experimental group, active control group, passive control group).
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auditory training: temporal cues
Arm Type
Experimental
Arm Description
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.
Arm Title
Auditory training: non-temporal cues
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Passive control group (Aims 1 and 2)
Arm Type
No Intervention
Arm Description
Listeners will be evaluated on pre-training and post-training tests, but will receive no training at all.
Intervention Type
Behavioral
Intervention Name(s)
Auditory training: temporal cues
Other Intervention Name(s)
Auditory training: non-temporal cues
Intervention Description
Behavioral training for 6-9 hours in listening to specific characteristics of acoustic signals. Listeners receive correct-answer feedback on each trial.
Primary Outcome Measure Information:
Title
Improvement in behavioral auditory temporal processing measures (Aim 1)
Description
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
Title
Improvement in recognition of trained stimuli - fast speech (Aim 2)
Description
Increase in speech rate at which listener maintains 50% and 80% correct recognition
Time Frame
completion of study, approximately 24 months
Secondary Outcome Measure Information:
Title
Change in spectral energy and neural phase locking for trained stimuli (Aim 1)
Description
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
Title
Change in phase locking to trained or equivalent stimuli (Aim 2)
Description
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
Title
Change in reconstruction accuracy to trained or equivalent stimuli (Aim 2)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Gordon-Salant, Ph.D.
Phone
3014054225
Email
sgsalant@umd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samira Anderson, Ph.D.
Phone
3014054224
Email
sander22@umd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Gordon-Salant, Ph.D.
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Gordon-Salant, Ph.D.
Phone
301-405-4225
Email
sgsalant@umd.edu
First Name & Middle Initial & Last Name & Degree
Samira Anderson, Ph.D.
Phone
3014054224
Email
sander22@umd.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Six months after publication until May 31, 2022
IPD Sharing 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.

Learn more about this trial

Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2

We'll reach out to this number within 24 hrs