Recruiting

Hearing Loss

Sponsor:

University of Colorado, Denver

Code:

NCT04513782

Conditions

Healthy Individuals

Hearing Loss, Central

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Audiological Assessments

Study Details

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.

Conditions

Healthy Individuals

Hearing Loss, Central

Study ID

NCT04513782

Start date

Oct 1, 2020

Status verified date

Aug, 2023

Completion date

May 29, 2026

Anticipated

Primary completion date

May 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

  • Speech in Noise Performance [ Time Frame: through study completion, an average of 6 years ]
  • Auditory Brainstem Response [ Time Frame: through study completion, an average of 6 years ]
  • Spatial Acuity [ Time Frame: through study completion, an average of 6 years ]

Central Contacts and Locations

Central contacts

Shaylene Denham

303-724-8465shaylene.denham@cuanschutz.edu

Locations

University of Colorado School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Laura Temple

303-724-8465laura.temple@cuanschutz.edu

Kristi Engle-Folchert

303-724-9528kristi.englefolchert@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 15, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-08-15.