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OpenTrials
Completed

NCT Number: NCT05064007

Sound and Music for 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.

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Key information

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

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

C: Preferred music

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

The Power of Sound and Music Interventions for Older Adults With Mild Cognitive Impairment

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 1, 2021
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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