Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2 (NCT03475043) | Clinical Trial Compass
CompletedNot Applicable
Neuroplasticity in Auditory Aging_Project 2 Aims 1 and 2
United States405 participantsStarted 2018-02-21
Plain-language summary
Millions of elderly adults in the USA have age related hearing loss (ARHL), a malady that affects half of adults 60-69 years, and the majority of older adults. This hearing loss not only impacts communication and functional ability, but also is strongly associated with cognitive decline and decreased quality of life. This project aims to develop effective strategies to compensate and reverse this process through a deeper understanding of plasticity and adaptive auditory function, and how to engage it and harness it to remedy ARHL.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* native speaker of English
* normal cognitive function as measured on Montreal Cognitive Assessment
* pass screening auditory brainstem response test to make sure they have recordable brainwaves to acoustic stimuli
* age and hearing sensitivity:
* young normal-hearing listeners, 18-35 years, hearing thresholds less than 25 decibels (dB) HL from 250 - 4000 Hz;
* older normal-hearing listeners, 65-85 years, hearing thresholds less than 25 dB HL, from 250-4000 Hz;
* older hearing-impaired listeners, 65-85 years, with mild-to-moderate, high frequency sensorineural hearing loss;
* high school diploma
Exclusion Criteria:
* absence of conductive hearing loss and middle-ear disease
* no neurological disease
* severe or profound hearing loss
* non-native speaker of English
* cognitive impairment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in behavioral auditory temporal processing measures (Aim 1)
Timeframe: completion of study, approximately 30 months
2
Improvement in recognition of trained stimuli - fast speech (Aim 2)
Timeframe: completion of study, approximately 24 months