- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475043
Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2
Neuroplasticity in Auditory Aging_Auditory Temporal processing_Project 2
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
College Park, Maryland, United States, 20742
- University of Maryland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 training for 6-9 hours in listening to specific characteristics of acoustic signals.
Listeners receive correct-answer feedback on each trial.
Other Names:
|
|
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 training for 6-9 hours in listening to specific characteristics of acoustic signals.
Listeners receive correct-answer feedback on each trial.
Other Names:
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
completion of study, approximately 30 months
|
|
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
|
completion of study, approximately 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in spectral energy and neural phase locking for trained stimuli (Aim 1)
Time Frame: completion of study, approximately 30 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
|
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
|
Increase in phase-locking factor following training of time-compressed speech, as measured in the frequency-following response
|
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
|
Increase in reconstruction accuracy following training of time-compressed speech, as measured with envelope tracking to five-minute speech samples
|
completion of study in approximately 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sandra Gordon-Salant, Ph.D., University of Maryland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Otorhinolaryngologic Diseases
- Ear Diseases
- Retrocochlear Diseases
- Auditory Diseases, Central
- Perceptual Disorders
- Auditory Perceptual Disorders
Other Study ID Numbers
- UMDCP_P01P2
- P01AG055365 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Auditory Perceptual Disorders
-
University of California, IrvineNational Institute on Aging (NIA)RecruitingAging | Auditory Perceptual ImpairmentUnited States
-
Medipol UniversityBahçeşehir UniversityCompletedVagus Nerve Stimulation | Auditory Processing Disorders | Auditory Processing Disorder, Central | Central Auditory DiseaseTurkey
-
Zonguldak Bulent Ecevit UniversityCompletedTelehealth | Central Auditory Processing DisorderTurkey
-
Jong Woo ChungCompletedAuditory Processing Disorder, CentralKorea, Republic of
-
Rana ElShafaeiAlexandria UniversityRecruitingDyslexia | Central Auditory Processing DisorderEgypt
-
Istanbul Aydın UniversityCompletedCentral Auditory Processing DisorderTurkey
-
University of ArkansasCompletedAuditory Processing DisorderUnited States
-
University College, LondonGN ResoundCompletedAuditory Processing Disorder
-
Children's Hearing Evaluation and Amplification...UnknownAuditory Processing DisorderUnited Kingdom
-
University Hospital MuensterPhonak AG, SwitzerlandUnknownAuditory Processing DisorderGermany, Switzerland
Clinical Trials on Auditory training: temporal cues
-
National Taiwan University HospitalCompletedParkinson's DiseaseTaiwan
-
Superior UniversityRecruitingParkinson DiseasePakistan
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingParkinson DiseaseUnited States
-
New York UniversityThe New York Eye & Ear InfirmaryCompletedHearing Loss, Sensorineural | Vestibular DisorderUnited States
-
Hasselt UniversityUniversity Ghent; Revalidatie & MS Centrum Overpelt; National MS Center MelsbroekCompleted
-
HsiuYun ChangCompletedParkinson DiseaseTaiwan
-
Hong Kong Baptist UniversityThe Hong Kong Polytechnic University; Education University of Hong KongCompletedAutism Spectrum DisorderHong Kong
-
Nottingham University Hospitals NHS TrustCompleted
-
Ospedale Generale Di Zona Moriggia-PelasciniUnknown
-
Kessler FoundationRecruitingTraumatic Brain InjuryUnited States