Recruiting

Music-based Intervention

Sponsor:

Rubato Life

Code:

NCT06163378

Conditions

Music

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rubato Life App

Study Details

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

Study ID

NCT06163378

Start date

Dec 1, 2023

Status verified date

Nov, 2023

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Mar 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: RUBATO

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;

no intervention: STANDARD OF CARE

patients will continue to receive standard of care.

Interventions

Rubato Life App

An algorithmically enhanced personalized music-based intervention

Primary outcome measure

  • Anxiety [ Time Frame: 12 weeks ]
  • Depression [ Time Frame: 12 weeks ]
  • Memory [ Time Frame: 12 weeks ]
  • Cognition [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Saint Elizabeth's Medical Center

Recruiting

Boston, Massachusetts, United States, 02135

Contacts

Oscar Salirrosas, MD, FACS

617-991-4279oscarsr1508@gmail.com

Claudius Conrad, MD,PhD,FACS

6177892442claudius.conrad@steward.org

Principal Investigator:

Claudius Conrad, MD,PhD,FACS

More Information

Sponsor

Rubato Life

Last update posted

Dec 8, 2023

Last verified

Nov, 2023

Keywords

  • Dementia
  • Music
  • Anxiety
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rubato Life on 2023-12-08.