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Neuroplasticity in Auditory Aging_Project 2

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ClinicalTrials.gov Identifier: NCT03475043
Recruitment Status : Suspended (coronavirus pandemic, no human subjects research at UMD)
First Posted : March 23, 2018
Last Update Posted : June 26, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sandra Gordon Salant, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE March 15, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE February 21, 2018
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Improvement in behavioral auditory temporal processing measures [ Time Frame: completion of study, approximately 7 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Change in spectral energy and neural phase locking for trained stimuli [ Time Frame: completion of study, approximately 7 months ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroplasticity in Auditory Aging_Project 2
Official Title  ICMJE Neuroplasticity in Auditory Aging_Auditory Temporal processing_Project 2
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 three specific aims: (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; (2) Determine the extent to which perceptual training on speech cue discrimination in contrasting words differing in discrete temporal cues improves perceptual and neural encoding in YNH, ONH, and OHI listeners; and (3) 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Experimental group Active control group Passive control group
Masking: Single (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).
Primary Purpose: Health Services Research
Condition  ICMJE
  • Auditory Perceptual Disorders
  • Aging Problems
Intervention  ICMJE Behavioral: Auditory training: temporal contrasts
Behavioral training for 9 hours in listening to specific characteristics of acoustic signals. Listeners receive correct-answer feedback on each trial.
Other Name: Auditory training: non-temporal contrasts
Study Arms  ICMJE
  • Experimental: Auditory training: temporal contrasts
    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.
    Intervention: Behavioral: Auditory training: temporal contrasts
  • Active Comparator: Auditory training: non-temporal contrasts
    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.
    Intervention: Behavioral: Auditory training: temporal contrasts
  • No Intervention: Passive control group
    Listeners will be evaluated on pre-training and post-training tests, but will receive no training at all.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 15, 2018)
405
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03475043
Other Study ID Numbers  ICMJE UMDCP_P01P2
P01AG055365 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: 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.
Responsible Party Sandra Gordon Salant, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Sandra Gordon-Salant, Ph.D. University of Maryland, College Park
PRS Account University of Maryland, College Park
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP