Recruiting

MCI

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06102486

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Mild Cognitive Impairment

Study ID

NCT06102486

Start date

May 18, 2024

Status verified date

Aug, 2026

Completion date

Sep 2, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

MCI

Participants diagnosed with or suspected to have MCI

Control

Participants without MCI

Primary outcome measure

  • Hearing-in-Noise Test Performance [ Time Frame: 1 time point (takes 15 minutes) ]
  • Triple Digit in Noise Test Performance [ Time Frame: 1 time point (takes 15 minutes) ]
  • Size of auditory neural response in background noise [ Time Frame: 1 time point (takes 45 minutes) ]
  • Timing of auditory neural response in background noise [ Time Frame: 1 time point (takes 45 minutes) ]

Central Contacts and Locations

Central contacts

Samantha Leigh, BS

5408195715samantha.m.leigh@dartmouth.edu

Locations

Space Medicine Lab at Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Samantha Leigh, BS

5408195715samantha.m.leigh@dartmouth.edu

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-08-25.