An observational study in Healthy Individuals and Hearing Loss, Central, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 40 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by University of Colorado, Denver · Observational
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's planned enrollment of 200 is above the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers
Subjects age ranges
a. 21 years (inclusive) and 89years (inclusive)
Exclusion Criteria:
Participants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss.
Speech in Noise Performance
Auditory perception task requiring participants to discriminate speech sound in quiet and in back ground noise. Takes about 90min.
Time frame: through study completion, an average of 6 years
Auditory Brainstem Response
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
Time frame: through study completion, an average of 6 years
Spatial Acuity
Auditory perception task requiring participants to judge the location of a sound. Takes about 90min
Time frame: through study completion, an average of 6 years
Working Memory Assessment
Reading span test to understand working memory capacity. Takes about 20min
Time frame: through study completion, an average of 6 years
Electrocorticogram
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.
Time frame: through study completion, an average of 6 years
Subject Questionnaires
Questionnaires administered to subject to gather information on health and hearing history, noise exposure, everyday listening. Takes about 30min.
Time frame: through study completion, an average of 6 years
TFS-AF
Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 20min.
Time frame: through study completion, an average of 6 years
Spectrotemporal Modulation
Two-alternative forced choice auditory perception task requiring participants to determine which sound has been modified. Takes about 30min
Time frame: through study completion, an average of 6 years
Plan to share: No
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University of Colorado, Denver