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Enrolling by invitation NCT06953700

Effects of Asymmetries on Binaural-Hearing Abilities Across the Lifespan

No phase Interventional Aging Hearing Loss Hearing Asymmetry

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Test of hearing function.
Who it may be relevant to
Registry conditions: Aging, Hearing Loss, Hearing Asymmetry. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Test of hearing function
    These are measurements of hearing acuity and spatial hearing.

Primary outcome measures

  • Sound localization [Time frame: After enrollment, in one visit lasting 1-2 hours]
  • Spatial release from masking [Time frame: After enrollment, in one visit lasting 1-2 hours]
Secondary outcome measures (5)
  • Basic binaural sensitivity [Time frame: After enrollment, in one visit lasting 1-2 hours]
  • Cognitive assessment [Time frame: After enrollment, in one visit lasting 1-2 hours]
  • Audiological assessment of hearing thresholds [Time frame: After enrollment, in one visit lasting ~1 hour]
  • Auditory Brainstem Response [Time frame: After enrollment, in one visit lasting ~1 hour]
  • Distortion-Product Otoacoustic Emissions [Time frame: After enrollment, in one visit lasting ~1 hour]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Maryland, College Park — College Park

Identifiers

NCT: NCT06953700 · 1959852 · 1R21DC021825

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗