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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG078917 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | this group will be exposed to condition A first, then B, and C |
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| 2 | Experimental | this group will be exposed to condition B first, then C, and A |
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| 3 | Experimental | this group will be exposed to condition C first, then A, and B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A: 40 Hz music | Behavioral | The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and Immediate after 4-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JUNXIN LI, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Nursing | Baltimore | Maryland | 21205 | United States |
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A total of 52 participants were consented. Fifteen participants who withdrew while waiting for randomization or 1st treatment were excluded. 37 participants were randomized.
Participants were recruited from multiple sources including community recruitment, memory clinics, and online recruitment platforms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: This Group Will be Exposed to Condition A First, Then B, and C | A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
| FG001 | Sequence 2: This Group Will be Exposed to Condition B First, Then C, and A | A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
| FG002 | Sequence 3: This Group Will be Exposed to Condition C First, Then A, and B | A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
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| Washout (10-14 Days) |
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| Second Intervention (4 Weeks) |
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| Washout (10-14 Days) |
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| Third Intervention (4 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence ABC | this group will be exposed to condition A first, then B, and C A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with data collected | Posted | Mean | Standard Deviation | z score | Baseline and 4 weeks |
|
During study participation, approximately 18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 40 Hz Music | No adverse events were reported | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Junxin Li | Johns Hopkins University | 4105022608 | junxin.li@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2024 | Jul 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| B: 40 Hz sound | Behavioral | The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks |
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| C: Preferred music | Behavioral | The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
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| BG001 | Sequence BCA | this group will be exposed to condition B first, then C, and A A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
| BG002 | Sequence CAB | This group will be exposed to condition C first, then A, and B A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Description |
|---|
| OG000 | 40 Hz Music | Participants who were assigned to listen to the 40 Hz music playlist one hour each day, 5 days a week, for 4 weeks |
| OG001 | 40 Hz Sound | The participants were assigned to listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks |
| OG002 | Preferred Music | The participants who were assigned to listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks |
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| Primary | 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. | Participants with data collected | Posted | Mean | Standard Deviation | z score | Baseline and Immediate after 4-week intervention |
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| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 40 Hz Sound | Three participants reported hearing buzzing sounds lasting 5 to 15 minutes following the completion of the listening sessions | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Preferred Music | No adverse events were reported | 0 | 32 | 0 | 32 | 0 | 32 |
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