NCT06953700

Brief 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). 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

April 15, 2025

Last Update Submit

April 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    After enrollment, in one visit lasting 1-2 hours

  • 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)

    After enrollment, in one visit lasting 1-2 hours

Secondary Outcomes (5)

  • Basic binaural sensitivity

    After enrollment, in one visit lasting 1-2 hours

  • Cognitive assessment

    After enrollment, in one visit lasting 1-2 hours

  • Audiological assessment of hearing thresholds

    After enrollment, in one visit lasting ~1 hour

  • Auditory Brainstem Response

    After enrollment, in one visit lasting ~1 hour

  • Distortion-Product Otoacoustic Emissions

    After enrollment, in one visit lasting ~1 hour

Study Arms (1)

Test of Hearing Function in Acoustic Hearing Listeners

EXPERIMENTAL
Diagnostic Test: Test of hearing function

Interventions

These are measurements of hearing acuity and spatial hearing.

Test of Hearing Function in Acoustic Hearing Listeners

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, College Park

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew J. Goupell, PhD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR
  • Michael P. Cummings, PhD

    University of Maryland, College Park

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

May 1, 2025

Study Start

June 17, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Following publication, available for at least seven years.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee.

Locations