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MCI Speech in Noise

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06102486
Collaborator
Dartmouth College (Other)
70
Enrollment
19
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Speech Perception in Noise as an Improved Marker for Neurocognitive Dysfunction
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2025
    Anticipated Study Completion Date :
    Jun 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    MCI

    Participants diagnosed with or suspected to have MCI
    Control

    Participants without MCI

    Outcome Measures

    Primary Outcome Measures

    1. Hearing-in-Noise Test Performance [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 [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 [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 [1 time point (takes 45 minutes)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    • Estimated premorbid intellectual functioning below a scaled score of 70 based on the Test of Premorbid Functioning (TOPF)

    • Non-correctable severe hearing or vision loss

    • Use of "Cognition Enhancing Drugs"

    • Frequent, severe headaches (occasional headaches or migraines are fine)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Dartmouth-Hitchcock Medical Center
    • Dartmouth College

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christopher E. Niemczak, Research Scientist, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT06102486
    Other Study ID Numbers:
    • STUDY02002079
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Oct 26, 2023