Sound and Music for Mild Cognitive Impairment

NCT ID: NCT05064007

Last Updated: 2025-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-04-03

Brief Summary

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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

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

A: 40 Hz music

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

2

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

Group Type EXPERIMENTAL

A: 40 Hz music

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

3

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

Group Type EXPERIMENTAL

A: 40 Hz music

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

C: Preferred music

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JUNXIN LI, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R21AG078917

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00295386

Identifier Type: -

Identifier Source: org_study_id

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