- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064007
Sound and Music for Mild Cognitive Impairment
November 27, 2023 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
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- 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
- Name: JUNXIN LI
- Phone Number: 4105022608
- Email: jli248@jhu.edu
Study Locations
-
-
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
Ages Eligible for Study
50 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
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 |
Intervention / Treatment |
---|---|
Experimental: 1
this group will be exposed to condition A first, then B, and C
|
The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks
The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks
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
|
The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks
The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks
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
|
The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks
The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognitive function
Time Frame: Baseline and immediately after the 4-week intervention
|
Cogstate computerized assessment will be used to measure cognitive function.
Higher score represents better cognitive function
|
Baseline and immediately after the 4-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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)
February 1, 2022
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
September 21, 2021
First Submitted That Met QC Criteria
September 22, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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University of California, San FranciscoNational Institute on Aging (NIA)Active, not recruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
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Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
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