Sound and Music for Mild Cognitive Impairment

NCT05064007 | Completed Results

• 2 other identifiers: IRB00295386R21AG078917
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

1

EXPERIMENTAL

this group will be exposed to condition A first, then B, and C

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

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

Behavioral: A: 40 Hz music; Behavioral: B: 40 Hz sound; Behavioral: C: Preferred music

Interventions

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

1; 2; 3

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

1; 2; 3

C: Preferred music BEHAVIORAL

The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks

1; 2; 3

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling
• amnesia mild cognitive impairment
• Preserved function
• No dementia

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Junxin Li
• Organization: Johns Hopkins University

junxin.li@jhu.edu

4105022608

Study Officials

• JUNXIN LI, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 1, 2021
• Study Start: February 1, 2022
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2025
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)