Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06163378 |
| Other study ID # |
RLM2 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Rubato Life |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
A. Specific Aims/Objectives:
- Primary Aim: Determine if Rubato Life (RL) music selection is effective making
improvements in the emotional, functional and cognitive dimensions of patients with
Dementia.
o H1: The investigators hypothesize that using personalized musical playlists, through
RL, will improve emotional, functional and cognitive outcomes for patients with
Dementia.
- Secondary Aim: Determine the incremental improvements in the emotional, functional and
cognitive dimensions from RL's music selection over standard of care.
- H2: The investigators hypothesize that the magnitude of emotional, functional and
cognitive improvements will be significantly higher for patients using RL than for
patients only with the standard of care.
B. Background and Significance
The field of music-based interventions (MBI) is growing rapidly as part of the treatment of
patients with chronic diseases such as dementia. MBI can be divided into Music Therapy (MT)
and Music Medicine (MM). In MT, patients are guided through a music intervention by a trained
music therapist. In MM, patients listen to live or recorded music without the personalized
care of a music therapist.
Even though, both of them can be carried out individually or in a group, it is important to
emphasize that the response to music is predominantly individual, such that the same song can
trigger different responses in different listeners. In that sense, traditional MM as compared
to MT lacks the personalization and moment-to-moment adjustments that may be necessary for
optimal outcomes, even more when it is administered in a group setting.
Regarding previous studies addressing the effects of music medicine in dementia, randomized
clinical trials are scarce and most of them focus on group music therapy interventions with a
small quantity of participants.
There is a need for a personalized approach in MM, which is economically more accessible,
since not all of patients are able to cover the cost of qualified therapist sessions. The
Rubato Life™ (RL) app uses a proprietary algorithm for music selection that uses
machine-learning and deep neural networks to select music, using real-time heart rate
variability, offering enhanced personalization of music selection.
C. Preliminary Studies:
There are no preliminary scientific studies regarding an algorithmically enhanced
personalized approach in Music Medicine to improve functional, cognitive, and emotional
dimensions of patients with dementia.
D. Design and Methodology:
1) Study Design
This longitudinal study will involve patients with Dementia will be enrolled. An interim
analysis will be performed after the first 20 patients' complete participation. Enrolled
patients will submit demographic, socioeconomic and medical information, initial music
preference, and will complete standardized questionnaires to establish baseline emotional,
functional and cognitional levels. (Geriatric Depression Scale, State-Trait Anxiety
Inventory, Dementia Quality of Life Questionnaire, Mini mental test and Immediate Prose
Memory test)
Patients will then be randomized 1:1 into 2 groups: (a) the intervention group in which
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; and (b) the control group in which patients will continue to receive
standard of care. On the day of their reassessment appointments, patients from both groups
will be asked to complete a new set of the aforementioned questionnaires to assess change in
emotional, functional or cognitive levels.
Data sources for this study will include: Demographic information questionnaires, State Trait
Anxiety Inventory (STAI-S) questionnaires, Geriatric Depression Scale questionnaires,
Dementia Quality of Life Questionnaires, Mini examinations of the mental state, Immediate
Prose Memory Tests, patient's medical records, and associated laboratory and imaging data.
3) Data Collection Methods, Assessments, Interventions and Schedule
- Demographic questionnaire
- Brief Music Experience Questionnaire (BMEQ)
- State-Trait Anxiety Inventory- State (STAI-S):
- Geriatric Depression Scale (GDS)
- Dementia Quality of Life Questionnaire (DQL)
- Mini examination of the mental state (Mini)
- Immediate Prose Memory Test (IPMT)
