MCI Speech in Noise

NCT06102486 | Recruiting

• 1 other identifier: STUDY02002079
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Hearing-in-Noise Test Performance

  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.

  1 time point (takes 15 minutes)

• Triple Digit in Noise Test Performance

  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.

  1 time point (takes 15 minutes)

• Size of auditory neural response in background noise

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

  1 time point (takes 45 minutes)

• Timing of auditory neural response in background noise

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

  1 time point (takes 45 minutes)

Study Arms (2)

MCI

Participants diagnosed with or suspected to have MCI

Control

Participants without MCI

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The community in and around Lebanon, NH and patients from DHMC.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Space Medicine Lab at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Samantha Leigh, BS

CONTACT

5408195715; samantha.m.leigh@dartmouth.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 26, 2023
• Study Start: May 18, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 2, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)