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The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss

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ClinicalTrials.gov Identifier: NCT04513782
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Age-related hearing loss, presbycusis, affects up to 50% of American adults. There are two main causes for presbycusis: 1) Progressive death of hair cells in the inner ear, and 2) Central hearing loss, or the reduced ability to decipher the sound source of interest from other competing sounds in a multi-source complex environment. The first cause is better understood and treatment options, such as hearing aids and cochlear implants, are available. However, central hearing loss is not as well understood and there is not a treatment available at this time. This study aims to advance our understanding of central hearing loss by evaluating the abilities of younger and older listeners in two primary outcome measures: to 1) neurologically process sound stimuli and 2) focus on conversational speech in the presence of spatially-separated competing background noise. A test using Auditory Brainstem Responses (ABR) will be used to evaluate the brain's response to clicking sounds.

This study will assess all waveform data, but will focus particularly on wave III. Sentence in noise tests will be used to assess each subject's ability to process speech in noisy situations. Both the ABR and sentence in noise tests are non-invasive and are commonly used in audiology practices to diagnosis and treat a variety of audiological pathologies.


Condition or disease Intervention/treatment
Healthy Individuals Hearing Loss, Central Diagnostic Test: Audiological Assessments

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 29, 2026
Estimated Study Completion Date : May 29, 2026

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Audiological Assessments
    Participants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss.


Primary Outcome Measures :
  1. Speech in Noise Performance [ Time Frame: through study completion, an average of 6 years ]
    Auditory perception task requiring participants to discriminate speech sound in quiet and in back ground noise. Takes about 90min.

  2. Auditory Brainstem Response [ Time Frame: through study completion, an average of 6 years ]
    Non-invasive auditory electrophysiological measure of brainstem electrical activity captured using electrodes placed on the scalp while sounds are played to one or both ears. Takes about 60min

  3. Spatial Acuity [ Time Frame: through study completion, an average of 6 years ]
    Auditory perception task requiring participants to judge the location of a sound. Takes about 90min


Secondary Outcome Measures :
  1. Working Memory Assessment [ Time Frame: through study completion, an average of 6 years ]
    Reading span test to understand working memory capacity. Takes about 20min

  2. Electrocorticogram [ Time Frame: through study completion, an average of 6 years ]
    Non-invasive auditory electrophysiological measure of brainstem electrical activity captured using electrodes placed on the scalp while sounds are played to one or both ears. Takes about 45min.

  3. Subject Questionnaires [ Time Frame: through study completion, an average of 6 years ]
    Questionnaires administered to subject to gather information on health and hearing history, noise exposure, everyday listening. Takes about 30min.

  4. TFS-AF [ Time Frame: through study completion, an average of 6 years ]
    Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 20min.

  5. Spectrotemporal Modulation [ Time Frame: through study completion, an average of 6 years ]
    Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 30min



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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers
Criteria

Inclusion Criteria:

  1. Subjects age ranges

    a. 21 years (inclusive) and 89years (inclusive)

  2. Subjects exhibiting no poorer than a mild hearing loss, defined as hearing thresholds no worse than 40dBHL at any test frequency 250-4000 Hz based on pure tone audiometry
  3. Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)

Exclusion Criteria:

  1. Patients outside the age range of 21-89
  2. Patients with an air-bone gap greater than 10dBHL at any frequency
  3. Patients who are decisionally challenged and/or unable to complete speech perception testing. These patients are excluded based on the study requiring behavioral responses to some tests
  4. Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.
  5. Illiterate patients
  6. Patients with neurodegenerative diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513782


Contacts
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Contact: Laura Temple 303-724-8465 laura.temple@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Laura Temple    303-724-8465    laura.temple@cuanschutz.edu   
Contact: Kristi Engle-Folchert    303-724-9528    kristi.englefolchert@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Melinda Anderson, PhD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04513782    
Other Study ID Numbers: 19-1213
R01DC017924 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Central
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural
Auditory Diseases, Central
Retrocochlear Diseases
Brain Diseases
Central Nervous System Diseases