- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06102486
MCI Speech in Noise
January 12, 2026 updated by: Christopher E. Niemczak, Dartmouth-Hitchcock Medical Center
Speech Perception in Noise as an Improved Marker for Neurocognitive Dysfunction
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samantha Leigh, BS
- Phone Number: 5408195715
- Email: samantha.m.leigh@dartmouth.edu
Study Locations
-
-
New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Recruiting
- Space Medicine Lab at Dartmouth-Hitchcock Medical Center
-
Contact:
- Samantha Leigh, BS
- Phone Number: 5408195715
- Email: samantha.m.leigh@dartmouth.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The community in and around Lebanon, NH and patients from DHMC.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
MCI
Participants diagnosed with or suspected to have MCI
|
|
Control
Participants without MCI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 time point (takes 15 minutes)
|
|
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.
|
1 time point (takes 15 minutes)
|
|
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).
|
1 time point (takes 45 minutes)
|
|
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).
|
1 time point (takes 45 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2024
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 2, 2026
Study Registration Dates
First Submitted
October 17, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
January 13, 2026
Last Update Submitted That Met QC Criteria
January 12, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02002079
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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