Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT04132362

Benefits of Personalised Music in Dementia - a Feasibility Study

Sponsor: Music for my Mind

View on ClinicalTrials.gov

Summary

There is growing evidence for the benefits of music for individuals living with dementia but there has been limited research looking specifically at personalised music. Methodologies have not yet been developed to generate and play personalised music playlists quickly and cost effectively. The research team proposes a feasibility study to develop effective methodologies for: i. efficient creation and delivery of personalised playlists for people with mild to moderate dementia in care homes; and ii. assessing their responses to this music. A long-list of personalised music (about 100 tracks) will be created by asking residents and their carers about the resident's musical tastes and background (particularly from their teenage years). A refined personalised playlist (of 10-20 tracks) will be created by playing excerpts from these tracks to the resident and gauging their responses including through direct feedback from the resident and their carer(s) plus observations of changes in facial expression, together with directly observed movements of hands, feet and/ or head, and changes in pulse rate (a monitor worn on the wrist to measure movement and pulse and the investigators will ask to film sessions). Care home staff and informal carers will use these playlists within the residents' care and the research team will use feedback from residents and carers to assess responses and explore whether factors such as the timing of listening or delivery methodology appear to affect the resident's well-being over time. The findings from this study will be used to develop automated approaches to playlist creation (e.g. an App) and to inform further feasibility studies to: test and refine methodologies for use with participants with more advanced dementia; and explore more systematically the benefits of personalised music and factors that affect this, ultimately to inform the design of a subsequent larger scale intervention study. Two substantial amendments were approved to this existing feasibility study on October 23, 2020. The two substantial amendments are: 1. To extend the main study to include participants who may lack capacity to consent. 2. A sub-study using fMRI to explore the mechanisms underlying reported beneficial effects of personalised music listening on behavioural and psychological symptoms in people living with dementia. A further amendment was approved in January 2021, to recruit 1000 families affected by dementia, living at home or in the community, to use our recently developed WebApp to create a personalised playlist for their loved one living with dementia and provide their perceptions of how the music has impacted the well-being of the person with dementia.

Official title: Generating and Using Personalised Music Playlists to Improve Behavioural and Psychological Symptoms in People With Dementia: a Feasibility Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1080

Start Date

2019-11-28

Completion Date

2026-04-30

Last Updated

2025-10-01

Healthy Volunteers

Conditions

Dementia

Interventions

BEHAVIORAL

Personalised music listening

People will be sequentially recruited to discover their favourite music playlist, monitor their emotional responses to specific songs and explore the impact of listening to the music, on their behavioural and psychological symptoms. This will be done through a one hour music listening session, to discover the top 10-20 songs they respond to. It will then be followed by multiple shorter music listening sessions, initiated by the dementia resident themselves or their carer, where they listen to their favourite songs during their day, before difficult moments of care or during visits with their families.

BEHAVIORAL

Using fMRI to investigate the effect of listening to personalised music evoking positive emotional response on brain activation

12 of the recruited participants, who have symptoms and signs of mild to moderate dementia will be invited to take part in this sub-study. Using an amended version of a previously employed fMRI paradigm, each study participant will be presented inside the MRI scanner with short 30 second epochs of music (identified as evoking a positive or neutral emotional response) in a block design. Each 30 second epoch of music will be followed by a 16 second period when participants will be asked to rate subjective changes in their affective state using a computerised visual analogue scale. Epochs of positive emotional stimuli will alternate with epochs of neutral emotional stimuli in a counterbalanced order of presentation in 2 runs of 10 epochs each (5 positive and 5 neutral in each run).

BEHAVIORAL

Personalised music listening in the community

1000 families affected by dementia will be invited to use our WebApp to create a personalised playlist for their loved one with dementia and share their perceptions of how the music has affected the well-being of their loved one.

Inclusion Criteria: A care home meeting all of the following criteria will be eligible to join the feasibility studies: * Is located in South East England; * Has at least 5 residents who care home staff estimate to be eligible for the studies; * Agrees to identify a suitable space for personalised music listening to be trialled; * Agrees to make staff available to select residents and support the studies; A resident meeting all of the following criteria will be eligible to participate in the feasibility studies: * A permanent resident within a care home run by the Quantum Care Home Group; * Has been assessed by suitably qualified/trained care home staff (or a medical professional) as having symptoms and signs of dementia (of any type). * Has one or more family member/carer willing to participate in this study by providing sufficient responses to a questionnaire about the resident's musical preferences and background and feedback on the resident's responses to listening to personalised music. * Has the ability to communicate in English; and * For participants who are assessed as lacking mental capacity to consent to participation, has an attorney or Consultee willing to support their inclusion in the study. An informal carer meeting all of the following criteria will be eligible to participate in the feasibility studies: * People above the age of 18 who are a family member or friend and act as an informal carer for a participant with dementia. * Has the ability to communicate in English. A care home staff meeting the following criteria will be eligible to participate in the feasibility study: * Health and social care staff, paid to provide care to individuals with dementia within participating care homes. This may include Managers, Registered Nursing staff, Care Assistants or Activity Coordinators. * Has the ability to communicate in English. Exclusion Criteria: A care home meeting any of the following criteria will not be eligible to join the feasibility study if it is: * Rated at the last Care Quality Commission (CQC) inspection as Needs Improvement or Inadequate; * Subject to CQC enforcement notices, admission bans or major CQC compliance issues; * Currently, or has recently been involved in, another research study or trial that conflicts with personalised music or with data collection during the course of these studies. A resident meeting any of the following criteria will not be eligible to participate in the feasibility studies: * Assessed by care home staff or a medical professional as having severe depression; * Assessed as being unable to hear music through headphones; * Is so severely physically impaired as to make it unlikely that the researchers, carers or informal carers will be able to observe responses to personalised music through (for example, changes in facial expression, tapping of feet or fingers etc) * Is currently, or has recently been involved in, another research study or trial that conflicts with personalised music listening or with data collection during the course of these studies; * Is expected to die before the completion of their participation in the study.

Locations (1)

Willow Court

Harpenden, Hertfordshire, United Kingdom

Clinical Research Directory

Benefits of Personalised Music in Dementia - a Feasibility Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)