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NCT Number: NCT06102486

MCI Speech in Noise

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Space Medicine Lab at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location status: Recruiting

Location contact

Samantha Leigh, BS

CONTACT

[email protected]

5408195715

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Hearing-in-Noise Test Performance

    Time frame: 1 time point (takes 15 minutes)

    The performance for Hearing in Noise Tests (HINT) between energetic masking and 2-talker informational masking (IM). Performance will be measured by the lowest signal-to-noise ratio (volume at which sentences are presented compared to background noise volume) that can be heard by the participant.

  2. Triple Digit in Noise Test Performance

    Time frame: 1 time point (takes 15 minutes)

    Performance for the behavioral Triple Digit (TDT) between energetic masking and 2-talker informational masking (IM). Performance will be measured by the lowest signal-to-noise ratio (volume at which digits are presented compared to background noise volume) that can be heard by the participant.

  3. Size of auditory neural response in background noise

    Time frame: 1 time point (takes 45 minutes)

    The change in amplitude of neural response between energetic masking and 2-talker informational masking (IM).

  4. Timing of auditory neural response in background noise

    Time frame: 1 time point (takes 45 minutes)

    The change in latency of neural response between energetic masking and 2-talker informational masking (IM).

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Leigh, BS

CONTACT

[email protected]

5408195715

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

Speech Perception in Noise as an Improved Marker for Neurocognitive Dysfunction

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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