Mild Cognitive ImpairmentNCT05064007
Sound and Music for Mild Cognitive Impairment
A study testing A: 40 Hz music, B: 40 Hz sound and C: Preferred music in people with Mild Cognitive Impairment, run by Johns Hopkins University at 1 site in United States.
Trial summary
Emerging studies in humans found that 40 Hz sound induces neural gamma oscillation and enhanced cognitive function in older adults with and without Alzheimer's Disease. We will compare a 40 Hz music intervention to both 40 Hz sound and music alone in a clinical cohort of older adults with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- A: 40 Hz music, B: 40 Hz sound and C: Preferred music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling
- amnesia mild cognitive impairment
- Preserved function
- No dementia
Who cannot join
- known diagnosis of schizophrenia or Parkinson's disease;
- severe hearing impairment;
- presence of an acute medical or psychiatric condition which would interfere with the subject's ability to follow the study protocol realistically
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: The Power of Sound and Music Interventions for Older Adults With Mild Cognitive Impairment
Emerging studies in humans found that 40 Hz sound induces neural gamma oscillation and enhanced cognitive function in older adults with and without Alzheimer's Disease. We will compare a 40 Hz music intervention to both 40 Hz sound and music alone in a clinical cohort of older adults with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- A: 40 Hz music, B: 40 Hz sound, C: Preferred music
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: 40 Hz musicBehavioural
The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks
B: 40 Hz soundBehavioural
The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks
C: Preferred musicBehavioural
The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | this group will be exposed to condition A first, then B, and C Receives: Behavioral: A: 40 Hz music; Behavioral: B: 40 Hz sound; Behavioral: C: Preferred music |
| 2 | Experimental | this group will be exposed to condition B first, then C, and A Receives: Behavioral: A: 40 Hz music; Behavioral: B: 40 Hz sound; Behavioral: C: Preferred music |
| 3 | Experimental | this group will be exposed to condition C first, then A, and B Receives: Behavioral: A: 40 Hz music; Behavioral: B: 40 Hz sound; Behavioral: C: Preferred music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic Memory Assessed by the Cogstate Alzheimer's Battery
The composite episodic memory score is calculated as a Z-score, representing the sum of the Z-scores across three Cogstate computerized assessments: One Card Learning, International Shopping List, and Delayed Recall. For each test, a Z-score is calculated relative to the first baseline assessment of all included subjects, using the formula (score - mean at first baseline assessment) / standard deviation at first baseline assessment. The composite Z-score is then calculated by summing these individual Z-scores. A composite Z-score of 0 corresponds to performance exactly at the study-sample mean at the first baseline assessment. Positive, or higher, composite Z-scores reflect better episodic-memory performance-they show how many standard deviations above the baseline mean the summed score lies. Conversely, negative, or lower, composite Z-scores reflect poorer episodic-memory performance, indicating how many standard deviations below the baseline mean the score falls.
Measured: Baseline and 4 weeks
Global Cognition Assessed by the Cogstate Alzheimer's Battery
The composite global cognitive score is expressed as a Z-score obtained by summing the Z-scores from six Cogstate computerized assessments: Identification, Detection, One Card Learning, One Back, International Shopping List-Delayed Recall, and Groton Maze Learning. For each task, an individual Z-score is calculated with reference to the first baseline assessment of all enrolled participants using the formula (individual score - baseline mean) / baseline standard deviation. These task-specific Z-scores are then summed to yield the composite value. A composite Z-score of 0 denotes performance exactly at the study-sample mean at the first baseline assessment. Positive-or higher-composite Z-scores reflect better global cognitive performance because they indicate performance a given number of standard deviations above that first baseline mean, whereas negative-or lower-composite Z-scores reflect poorer performance by indicating the number of standard deviations below the mean.
Measured: Baseline and Immediate after 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Feb 2022
- Primary completion3 Apr 2024
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- JUNXIN LI, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064007
- Sponsor's protocol ID
- IRB00295386
- Other IDs
- R21AG078917
- Status last verified
- Aug 2025
- First submitted
- 21 Sep 2021
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Power of Sound and Music Interventions for Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05064007
- Acronym / sponsor ID
- IRB00295386
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emerging studies in humans found that 40 Hz sound induces neural gamma oscillation and enhanced cognitive function in older adults with and without Alzheimer's Disease. We will compare a 40 Hz music intervention to both 40 Hz sound and music alone in a clinical cohort of older adults with mild cognitive impairment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: A: 40 Hz music, Behavioral: B: 40 Hz sound, Behavioral: C: Preferred musicthis group will be exposed to condition A first, then B, and C |
| 2 | Experimental | Behavioral: A: 40 Hz music, Behavioral: B: 40 Hz sound, Behavioral: C: Preferred musicthis group will be exposed to condition B first, then C, and A |
| 3 | Experimental | Behavioral: A: 40 Hz music, Behavioral: B: 40 Hz sound, Behavioral: C: Preferred musicthis group will be exposed to condition C first, then A, and B |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Community-dwelling
- amnesia mild cognitive impairment
- Preserved function
- No dementia
Key exclusion criteria (3 listed)
- known diagnosis of schizophrenia or Parkinson's disease;
- severe hearing impairment;
- presence of an acute medical or psychiatric condition which would interfere with the subject's ability to follow the study protocol realistically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A: 40 Hz musicThe participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks | Behavioural | 1, 2, 3 |
| B: 40 Hz soundThe participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks | Behavioural | 1, 2, 3 |
| C: Preferred musicThe participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks | Behavioural | 1, 2, 3 |
Primary outcome
Episodic Memory Assessed by the Cogstate Alzheimer's Battery
Time frame: Baseline and 4 weeks
The composite episodic memory score is calculated as a Z-score, representing the sum of the Z-scores across three Cogstate computerized assessments: One Card Learning, International Shopping List, and Delayed Recall. For each test, a Z-score is calculated relative to the first baseline assessment of all included subjects, using the formula (score - mean at first baseline assessment) / standard deviation at first baseline assessment. The composite Z-score is then calculated by summing these individual Z-scores. A composite Z-score of 0 corresponds to performance exactly at the study-sample mean at the first baseline assessment. Positive, or higher, composite Z-scores reflect better episodic-memory performance-they show how many standard deviations above the baseline mean the summed score lies. Conversely, negative, or lower, composite Z-scores reflect poorer episodic-memory performance, indicating how many standard deviations below the baseline mean the score falls.
Global Cognition Assessed by the Cogstate Alzheimer's Battery
Time frame: Baseline and Immediate after 4-week intervention
The composite global cognitive score is expressed as a Z-score obtained by summing the Z-scores from six Cogstate computerized assessments: Identification, Detection, One Card Learning, One Back, International Shopping List-Delayed Recall, and Groton Maze Learning. For each task, an individual Z-score is calculated with reference to the first baseline assessment of all enrolled participants using the formula (individual score - baseline mean) / baseline standard deviation. These task-specific Z-scores are then summed to yield the composite value. A composite Z-score of 0 denotes performance exactly at the study-sample mean at the first baseline assessment. Positive-or higher-composite Z-scores reflect better global cognitive performance because they indicate performance a given number of standard deviations above that first baseline mean, whereas negative-or lower-composite Z-scores reflect poorer performance by indicating the number of standard deviations below the mean.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
JUNXIN LI, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A: 40 Hz music, B: 40 Hz sound and C: Preferred music in people with Mild Cognitive Impairment, run by Johns Hopkins University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodic Memory Assessed by the Cogstate Alzheimer's Battery (time frame: Baseline and 4 weeks). The study lists 2 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 29 Aug 2025.