Sound and Music for Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: A: 40 Hz music; Behavioral: B: 40 Hz sound; Behavioral: C: Preferred music

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Community-dwelling
2. amnesia mild cognitive impairment
3. Preserved function
4. No dementia

Exclusion Criteria:

1. known diagnosis of schizophrenia or Parkinson's disease;
2. severe hearing impairment;
3. presence of an acute medical or psychiatric condition which would interfere with the subject's ability to follow the study protocol realistically

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; this group will be exposed to condition A first, then B, and C	Behavioral: 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; Behavioral: 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; Behavioral: C: Preferred music; The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
Experimental: 2; this group will be exposed to condition B first, then C, and A	Behavioral: 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; Behavioral: 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; Behavioral: C: Preferred music; The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
Experimental: 3; this group will be exposed to condition C first, then A, and B	Behavioral: 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; Behavioral: 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; Behavioral: C: Preferred music; The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: JUNXIN LI, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 3, 2024
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: IRB00295386; R21AG078917 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No