Effects of an Algorithmically Enhanced Personalized Music-based Intervention in Patients With Dementia

NCT06163378 | Unknown FDA Device

• 1 other identifier: RLM2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This 6 - 12 week longitudinal study will include patients with Dementia. Participants will be randomized into one of two groups: a) an intervention group, in which patients will listen to music using Rubato Life app, and b) a control group, in which patients will receive standard of care. Patients in intervention group will be asked to listen to at least 30 minutes per day, (or a total of 3.5 hours per week) for a period of 6 -12 weeks, coming up to their scheduled follow up appointment. Patients in the Intervention group will wear smartwatches to monitor heart rate variability throughout the study.

Conditions

Music

Keywords

Dementia; Music; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• Anxiety

  Will be assessed using the State-Trait Anxiety Inventory- State (STAI-S)

  12 weeks

• Depression

  Will be assessed using the Geriatric Depression Scale (GDS)

  12 weeks

• Memory

  Will be assessed using the Immediate Prose Memory Test (IPMT)

  12 weeks

• Cognition

  Will be assessed using the Mini examination of the mental state (Mini)

  12 weeks

Study Arms (2)

RUBATO

EXPERIMENTAL

patients will be asked to listen (using headphones to accommodate patients with hearing aid) to a minimum of 30 minutes per day of music (or a total of 3.5 hours per week), coming up to their scheduled reassessment appointments (every 6 to 12 weeks) using the RL music selection application while wearing an individual smart bracelet aimed to build their optimal music therapy profile;

Device: Rubato Life App

STANDARD OF CARE

NO INTERVENTION

patients will continue to receive standard of care.

Interventions

Rubato Life App DEVICE

An algorithmically enhanced personalized music-based intervention

RUBATO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Diagnosed with Dementia, requiring reassessment every 3 month
• Have access to a smartphone and able to operate smartphone (or their caretaker)
• Have a Google or Apple ID. (or their caretaker)

You may not qualify if:

• Participants with hearing disorders who do not use hearing aids
• Participants who have extreme dislike of music.
• Participants who cannot comply with the minimum time Rubato Life application requires to be used. (or their caretaker)

Sponsors & Collaborators

• Rubato Life: lead

Study Sites (1)

Saint Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)