- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953700
Effects of Asymmetries on Binaural-Hearing Abilities Across the Lifespan
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
College Park, Maryland, United States, 20742
- University of Maryland, College Park
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18-80 years)
- No hearing asymmetry between ears (≤10 dB at any frequency) or, hearing asymmetry between ears >10 dB
- Native English speakers
- Primarily use oral language
- Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text
Exclusion Criteria:
- Acoustic tone-detection threshold >50 dB HL at any octave frequency (250-4000 Hz) in either ear (i.e., more than a moderate hearing loss)
- History of neurological disorders (e.g., stroke, Parkinson's disease) determined by self-report
- History of post-traumatic stress disorder or traumatic brain injury determined by self-report
- Possibility of acoustic neuroma, hearing asymmetry (>10 dB at three consecutive audiometric threshold frequencies)
- Montreal Cognitive Assessment (MoCA) score <22/30
- No oral language use
- Cochlear implant user
- Conductive hearing loss
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Test of Hearing Function in Acoustic Hearing Listeners
|
These are measurements of hearing acuity and spatial hearing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sound localization
Time Frame: After enrollment, in one visit lasting 1-2 hours
|
A measure of sound localization ability (summarizing the ability using broadband and narrowband noise stimuli).
Localization is the ability to accurately report the location from which a sound source originated.
The difference between actual and reported locations is used for the measure.
(Units, angle measure in degrees)
|
After enrollment, in one visit lasting 1-2 hours
|
|
Spatial release from masking
Time Frame: After enrollment, in one visit lasting 1-2 hours
|
A measure of speech understanding.
Spatial release from masking is calculated by finding the difference in thresholds between listening with co-located vs. separated masking signals.
(Units, dB)
|
After enrollment, in one visit lasting 1-2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Basic binaural sensitivity
Time Frame: After enrollment, in one visit lasting 1-2 hours
|
A summary measure of basic binaural sensitivity (discrimination thresholds) that uses both frequency-specific and more broadband stimuli that differ in interaural time and level cues.
(Units dB)
|
After enrollment, in one visit lasting 1-2 hours
|
|
Cognitive assessment
Time Frame: After enrollment, in one visit lasting 1-2 hours
|
A control measurement for factors that may contribute to hearing deficit.
The standardized Montreal Cognitive Assessment cognitive screener and NIH Toolbox subscores for Working Memory, Processing Speed, and Attention will be combined to summarize a potential cognitive contribution to hearing deficits.
(Units, points.)
|
After enrollment, in one visit lasting 1-2 hours
|
|
Audiological assessment of hearing thresholds
Time Frame: After enrollment, in one visit lasting ~1 hour
|
Measurement of hearing thresholds by presenting sounds of specific frequencies via audiometer and recording the lowest level that can be detected for each frequency.
These thresholds are then averaged.
(Units, dB)
|
After enrollment, in one visit lasting ~1 hour
|
|
Auditory Brainstem Response
Time Frame: After enrollment, in one visit lasting ~1 hour
|
A non-invasive measure of auditory processing integrity past the point of the cochlea.
Earphones are used to present brief acoustic click stimuli and waveform recordings of neural activity at the level of the brainstem are collected via surface sensors on the listener's head.
(Unit, latency in milliseconds)
|
After enrollment, in one visit lasting ~1 hour
|
|
Distortion-Product Otoacoustic Emissions
Time Frame: After enrollment, in one visit lasting ~1 hour
|
A measurement of the inner ear's acoustic response to a brief stimulus played in the ear canal.
This can provide information about the integrity of the cochlea's outer hair cells.
(Units, dB SNR (signal to noise ratio))
|
After enrollment, in one visit lasting ~1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Matthew J. Goupell, PhD, University of Maryland, College Park
- Study Director: Michael P. Cummings, PhD, University of Maryland, College Park
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 1959852
- 1R21DC021825 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. De-identified data relevant to the project will be disseminated to researchers on and off-campus by request and review of the PI.
After publication, research products from this project will be archived at the Digital Repository at the University of Maryland (DRUM) (unless a more appropriate facility can be identified). DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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.
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