Sound and Music for Mild Cognitive Impairment

August 28, 2025 updated by: Johns Hopkins University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks
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.
Baseline and Immediate after 4-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JUNXIN LI, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Cognitive Impairment

Clinical Trials on A: 40 Hz music

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings