Mild Cognitive ImpairmentNCT06102486
MCI Speech in Noise
An observational study of Mild Cognitive Impairment, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2024to 2 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The community in and around Lebanon, NH and patients from DHMC.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Space Medicine Lab at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Samantha Leigh, BS, 5408195715, samantha.m.leigh@dartmouth.edu
About this study
Official title: 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.
- Conditions
- Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCI | Participants diagnosed with or suspected to have MCI | |
| Control | Participants without MCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 1 time point (takes 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start18 May 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Jay C. Buckey Jr., Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102486
- Sponsor's protocol ID
- STUDY02002079
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Perception in Noise as an Improved Marker for Neurocognitive Dysfunction
- ClinicalTrials.gov ID
- NCT06102486
- Acronym / sponsor ID
- STUDY02002079
- Conditions
- Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 18 May 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI | – | –Participants diagnosed with or suspected to have MCI |
| Control | – | –Participants without MCI |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The community in and around Lebanon, NH and patients from DHMC.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Related trials for Mild Cognitive Impairment
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Enrolling by invitation
Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI
Mild Cognitive Impairment
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Leigh, BS (5408195715, samantha.m.leigh@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing-in-Noise Test Performance (time frame: 1 time point (takes 15 minutes)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.