Sound and Music for Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT05064007
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-01
• Study Start: 2022-02-01
• Primary Completion: 2024-04-03
• Study Completion: 2025-04-03
• Results First Submitted: 2025-07-31
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Results First Posted: 2025-08-29
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Episodic Memory Assessed by the Cogstate Alzheimer's Battery	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.
Global Cognition Assessed by the Cogstate Alzheimer's Battery	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.

Trial Locations

Locations (1)

Johns Hopkins School of Nursing; 🇺🇸 Baltimore, Maryland, United States