Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2

NCT03475043 | Completed

• 2 other identifiers: UMDCP_P01P2P01AG055365
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Perceptual Disorders; Aging Problems

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change in spectral energy and neural phase locking for trained stimuli (Aim 1)

  completion of study, approximately 30 months

• Change in phase locking to trained or equivalent stimuli (Aim 2)

  completion of study in approximately 24 months

• Change in reconstruction accuracy to trained or equivalent stimuli (Aim 2)

  completion of study in approximately 24 months

Study Arms (3)

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.

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.

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.

Interventions

Auditory training: temporal cues BEHAVIORAL

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

Auditory training: non-temporal cues; Auditory training: temporal cues

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• absence of conductive hearing loss and middle-ear disease
• no neurological disease
• severe or profound hearing loss
• non-native speaker of English
• cognitive impairment

Sponsors & Collaborators

• University of Maryland, College Park: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Auditory Perceptual Disorders

Condition Hierarchy (Ancestors)

Auditory Diseases, Central; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sandra Gordon-Salant, Ph.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Experimental group Active control group Passive control group

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 23, 2018
• Study Start: February 21, 2018
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)