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Sound and Music for Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A: 40 Hz music
B: 40 Hz sound
C: Preferred music
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins School of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Cognitive function
Cogstate computerized assessment will be used to measure cognitive function. Higher score represents better cognitive function

Secondary Outcome Measures

Full Information

First Posted
September 21, 2021
Last Updated
February 20, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05064007
Brief Title
Sound and Music for Mild Cognitive Impairment
Official Title
The Power of Sound and Music Interventions for Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
this group will be exposed to condition A first, then B, and C
Arm Title
2
Arm Type
Experimental
Arm Description
this group will be exposed to condition B first, then C, and A
Arm Title
3
Arm Type
Experimental
Arm Description
this group will be exposed to condition C first, then A, and B
Intervention Type
Behavioral
Intervention Name(s)
A: 40 Hz music
Intervention Description
The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
B: 40 Hz sound
Intervention Description
The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
C: Preferred music
Intervention Description
The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
Primary Outcome Measure Information:
Title
Change in Cognitive function
Description
Cogstate computerized assessment will be used to measure cognitive function. Higher score represents better cognitive function
Time Frame
Baseline and immediately after the 4-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JUNXIN LI
Phone
4105022608
Email
jli248@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUNXIN LI, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junxin LI
Email
junxin.li@jhu.edu
First Name & Middle Initial & Last Name & Degree
Mengchi Li
Email
mli121@jhu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sound and Music for Mild Cognitive Impairment

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