A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD)

Dementia Clinical Trial

Official title:

A Music-Based Mobile App to Combat Neuropsychiatric Symptoms in People Living With ADRD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140342
• Other study ID #: 3-P30-AG-073105-02 SUPPLEMENT
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Autotune Me LLC
• Contact: Kendra Ray, PhD, MBA, MPH
• Phone: 347-636-7157
• Email: kendra[@]autotuneme.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria for person with dementia

• A person with ADRD exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.

• Stability with or without psychotropic or anti-depressant medications

• Ability to hear with or without an assistive device

Inclusion Criteria for Caregivers

• Family or close friend caregiver of persons with dementia

• Must be able to read and write in basic English

Exclusion Criteria for all participants

• Inadequate hearing

• History of psychosis or other mental disorders other than depression

• Presence of substance or alcohol abuse

Related Conditions & MeSH terms

• Agitation
• Dementia
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Feasibility study of music-based mobile app
To determine the performance and usability of the app, 20 dyads will be recruited to test it for 2 weeks. The investigators will collect physiological measures based on the application's demonstration to auto-play music according to movement or sedentary states.

Locations

Country	Name	City	State
United States	Autotune Me, LLC	Brooklyn	New York

Sponsors (3)

Lead Sponsor	Collaborator
Autotune Me LLC	National Institute on Aging (NIA), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of mobile app	Dyads of caregivers of people with dementia and their caregivers will wear a smartwatch and test the music-based mobile app for two weeks. The person with dementia will wear the smartwatch that will connect to the mobile app for 2 weeks. Caregivers will be asked to complete a daily checklist of their care recipients' behaviors for two weeks.; Participants will complete the Usefulness, Satisfaction and Ease of Use questionnaire that describes the usability of the mobile app. The minimum score is 30 while the maximum score is 240. The higher the score means the usability of the app is more acceptable.	2 weeks