| NCT ID | NCT06102486 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dartmouth-Hitchcock Medical Center |
| Condition | Mild Cognitive Impairment |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-05-18 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2024-05-18 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 hearing or vision loss * Use of "Cognition Enhancing Drugs" * Frequent, severe headaches (occasional headaches or migraines are fine)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06102486 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06102486 currently recruiting?
Yes, NCT06102486 is actively recruiting participants. Contact the research team at samantha.m.leigh@dartmouth.edu for enrollment information.
Where is the NCT06102486 trial being conducted?
This trial is being conducted at Lebanon, United States.
Who is sponsoring the NCT06102486 clinical trial?
NCT06102486 is sponsored by Dartmouth-Hitchcock Medical Center. The trial plans to enroll 70 participants.