Sound and Music for Mild Cognitive Impairment

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05064007

Collaborator

(none)

Enrollment

Location

Arms

33.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Behavioral: A: 40 Hz music Behavioral: B: 40 Hz sound Behavioral: C: Preferred music	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 5, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in Cognitive function [Baseline and immediately after the 4-week intervention]
Cogstate computerized assessment will be used to measure cognitive function. Higher score represents better cognitive function

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Nursing	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: JUNXIN LI, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT05064007

Other Study ID Numbers:

IRB00295386

First Posted:

Oct 1, 2021

Last Update Posted:

Jan 5, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Jan 5, 2022