Effects of Asymmetries on Binaural-Hearing Abilities Across the Lifespan

April 23, 2025 updated by: University of Maryland, College Park
Binaural hearing involves combining auditory information across the ears. With binaural hearing, listeners benefit from perceiving sounds from different spatial locations. This is critical in solving the "cocktail party problem" (i.e., understanding speech in the presence of competing background sounds and noise). As humans get older, hearing loss increases, binaural abilities decrease, and the cocktail party problem becomes increasingly difficult. This research studies the mechanisms underlying the impact of age and hearing loss on speech-perception in noise and cocktail-party listening situations. More specifically, the role of hearing asymmetries between the ears is investigated. The specific aims are to generate an audiological and binaural-hearing-focused dataset for a large cohort of participants that vary in hearing asymmetry, age, and hearing loss and to use machine learning to uncover complex associations and generate novel hypotheses relating audiometric variables and basic binaural-hearing abilities to the cocktail-party problem. Participants in this research will complete perceptual measures of hearing acuity and spatial hearing. Participants will also report on speech understanding under noisy and challenging listening conditions. This research may lead to improvements in audiological care and hearing interventions.

Study Overview

Status

Enrolling by invitation

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland, College Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1959852
  • 1R21DC021825 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

Following publication, available for at least seven years.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Aging

Clinical Trials on Test of hearing function

Subscribe