Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163378
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-20
Brief Title:
Effects of an Algorithmically Enhanced Personalized Music-based Intervention in Patients With Dementia
Sponsor:
Rubato Life
Organization:
Rubato Life
Study Overview
Official Title:
Effects of an Algorithmically Enhanced Personalized Music-based Intervention in Patients
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 35 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
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 35 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
Detailed Description:
A Specific AimsObjectives
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 RLs 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 11 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 35 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 patients 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
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 RLs 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 11 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 35 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None