RecruitingNot Applicable

MCI Speech in Noise

United States70 participantsStarted 2024-05-18

Plain-language summary

The purpose of this study is to determine whether people with MCI (Mild Cognitive Impairment) and healthy comparison subjects differ with respect to their ability to hear soft sounds and how their brain understands and processes sound. The investigators are also evaluating, within those with MCI, whether the hearing tests are associated with neurocognitive functioning. The investigators are interested in learning whether changes in cognition in those with MCI can be detected using tests of how the brain processes sound. The investigators hypothesize that participants with MCI will score worse on both hearing tests and neurocognitive tests than participants without MCI. Participants are asked to complete multiple types of hearing tests, take a series of neurocognitive tests, and complete a few questionnaires.

Who can participate

Age range

55 Years – 80 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: * Adults diagnosed with or suspected to have MCI (for MCI group) or are cognitively normal (for Control group) * Absence of other risk factors that might affect CAP (Central Auditory Processing) performance (e.g., active ear infections, congenital developmental delay, severe hearing loss) * Age 55-80 * Normal hearing sensitivity (\<40 dB HL Pure Tone Average (average of 500, 1000, 2000 Hz) thresholds bilaterally * Normal middle ear function defined by tympanometry (0.3-2.0 ml) * Native English speaker Exclusion Criteria: * Active ear infections or abnormal middle ear pathology * Other health condition prohibiting the completion of the CAP test battery * Mild to profound peripheral hearing loss (\>40 dB (decibel) HL (hearing loss) Pure Tone Average (average of 500, 1000, 2000 Hz) bilaterally * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * History of CNS (Central Nervous System) disorder that might severely impact cognitive function (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, neurosyphilis, intracranial tumors, history of significant head trauma with loss of consciousness (≥30 min), and cerebrovascular disease) * Severe mental illness (e.g., schizophrenia, bipolar disorder) * Current, uncontrolled medical condition that could affect cognition (e.g., hypertension) * History of substance use disorder within the (other than nicotine/caffeine) * Non-correctable severe hearin…

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

Hearing-in-Noise Test Performance

Timeframe: 1 time point (takes 15 minutes)

Triple Digit in Noise Test Performance

Timeframe: 1 time point (takes 15 minutes)

Size of auditory neural response in background noise

Timeframe: 1 time point (takes 45 minutes)

Timing of auditory neural response in background noise

Timeframe: 1 time point (takes 45 minutes)

Trial details

NCT IDNCT06102486

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

Contact for this trial

Samantha Leigh, BS

5408195715 samantha.m.leigh@dartmouth.edu

View on ClinicalTrials.gov More Mild Cognitive Impairment trials

Plain-language summary

Who can participate

Age range

55 Years – 80 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.

What they're measuring

Hearing-in-Noise Test Performance

Timeframe: 1 time point (takes 15 minutes)

Triple Digit in Noise Test Performance

Timeframe: 1 time point (takes 15 minutes)

Size of auditory neural response in background noise

Timeframe: 1 time point (takes 45 minutes)

Timing of auditory neural response in background noise

Timeframe: 1 time point (takes 45 minutes)