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AgingNCT06953700

Effects of Asymmetries on Binaural-Hearing Abilities Across the Lifespan

A study testing Test of hearing function in people with Aging and Hearing Loss, run by University of Maryland, College Park at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Aging, Hearing Loss, Hearing Asymmetry
What is being tested?
Test of hearing function
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
17 Jun 2024to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Maryland, College Park

    College Park, Maryland, 20742

Other trials in United States

About this study

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.

Being tested
Test of hearing function
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test of hearing functionDiagnostic test

    These are measurements of hearing acuity and spatial hearing.

Study groups in NCT06953700
Study groupRoleWhat they receive
Test of Hearing Function in Acoustic Hearing ListenersExperimentalNot described
Receives: Diagnostic Test: Test of hearing function

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sound localization

    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)

    Measured: After enrollment, in one visit lasting 1-2 hours

  2. Spatial release from masking

    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)

    Measured: After enrollment, in one visit lasting 1-2 hours

Secondary outcomes (5)

  1. Basic binaural sensitivity

    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)

    Measured: After enrollment, in one visit lasting 1-2 hours

  2. Cognitive assessment

    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.)

    Measured: After enrollment, in one visit lasting 1-2 hours

  3. Audiological assessment of hearing thresholds

    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)

    Measured: After enrollment, in one visit lasting ~1 hour

  4. Auditory Brainstem Response

    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)

    Measured: After enrollment, in one visit lasting ~1 hour

  5. Distortion-Product Otoacoustic Emissions

    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))

    Measured: After enrollment, in one visit lasting ~1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start17 Jun 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06953700
Sponsor's protocol ID
1959852
Other IDs
1R21DC021825
Status last verified
Apr 2025
First submitted
15 Apr 2025
Last updated
1 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Test of hearing function in people with Aging and Hearing Loss, run by University of Maryland, College Park at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sound localization (time frame: After enrollment, in one visit lasting 1-2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06953700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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