Healthy IndividualsNCT04513782
The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss
An observational study of Healthy Individuals and Hearing Loss, Central, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Hearing Loss, Central
- What is being tested?
- Audiological Assessments
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 29 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Subjects age ranges
- 21 years (inclusive) and 89years (inclusive)
- 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
- Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)
Who cannot join
- Patients outside the age range of 21-89
- Patients with an air-bone gap greater than 10dBHL at any frequency
- 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
- Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.
- Illiterate patients
- Patients with neurodegenerative diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado School of Medicine
Aurora, Colorado, 80045
Laura Temple, 303-724-8465, laura.temple@cuanschutz.edu
Kristi Engle-Folchert, 303-724-9528, kristi.englefolchert@cuanschutz.edu
About this study
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
- Being tested
- Audiological Assessments
- Medical subject headings
- Hearing Loss, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiological AssessmentsDiagnostic test
Participants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss.
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in Noise Performance
Auditory perception task requiring participants to discriminate speech sound in quiet and in back ground noise. Takes about 90min.
Measured: 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
Measured: 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
Measured: through study completion, an average of 6 years
Secondary outcomes (5)
Working Memory Assessment
Reading span test to understand working memory capacity. Takes about 20min
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Oct 2020
- Primary completion29 May 2026 (estimated)
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Daniel Tollin, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513782
- Sponsor's protocol ID
- 19-1213
- Other IDs
- R01DC017924
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2020
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss
- ClinicalTrials.gov ID
- NCT04513782
- Acronym / sponsor ID
- 19-1213
- Conditions
- Healthy Individuals, Hearing Loss, Central
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- Subjects age ranges
- 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
- Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)
Key exclusion criteria (6 listed)
- Patients outside the age range of 21-89
- Patients with an air-bone gap greater than 10dBHL at any frequency
- 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
- Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.
- Illiterate patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiological AssessmentsParticipants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss. | Diagnostic test | – |
Primary outcome
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.
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
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
5 secondary outcomes
Working Memory Assessment
Time frame: through study completion, an average of 6 years
Electrocorticogram
Time frame: through study completion, an average of 6 years
Subject Questionnaires
Time frame: through study completion, an average of 6 years
TFS-AF
Time frame: through study completion, an average of 6 years
Spectrotemporal Modulation
Time frame: through study completion, an average of 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy Individuals
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Tollin, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals and Hearing Loss, Central, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaylene Denham (303-724-8465, shaylene.denham@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech in Noise Performance (time frame: through study completion, an average of 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.