MCI Speech in Noise

Mild Cognitive Impairment Clinical Trial

Official title:

Speech Perception in Noise as an Improved Marker for Neurocognitive Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102486
• Other study ID #: STUDY02002079
• Status: Recruiting
• Start date: May 18, 2024
• Est. completion date: December 2, 2025

Study information

• Verified date: June 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Samantha Leigh, BS
• Phone: 5408195715
• Email: samantha.m.leigh[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	Space Medicine Lab at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)