Clinical trial NCT06880237: Sing Out Loud: a Choral Singing Program for Persons Living with Dementia
Official title: Sing Out Loud: a Choral Singing Program for Persons Living with Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Nursing Homes Residents
Keywords: Dementia
Nursing Home Residents
Singing
Biomarkers
NPI-Q
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Esplanade
name: APEX Harmony Lodge
First posted: 2025-03-17
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We intend to investigate whether a singing programme for nursing home residents living with dementia can reduce the mental and physiological effects of dementia. The main questions it aims to answer are:

1. Does participating in the Sing Out Loud (SOL) singing intervention lead to an improvement in the physiological well-being (increase in oxytocin and reduction in cortisol levels) of persons living with dementia (PWDs) in nursing homes?
2. Will participation in the SOL singing intervention result in an improvement in PWDs' overall mood, temperament, and mental health (indicated by symptoms such as apathy, aggression, and depression).

Researchers will compare the singing group to the control group to see if they exhibit reduced levels of apathy, aggression, and depression, and whether their levels of oxytocin and cortisol (collected via salivary biomarkers) have increased and decreased, respectively.

Researchers will compare the SOL singing intervention with a waitlist control group to see if the SOL singing intervention increases the feelings of social connection, reduces stress, or improves the symptoms of dementia in nursing home residents.

Participants will be randomly assigned to a singing intervention or waitlist control group. The intervention involves an 8-week long singing programme with one practice session a week, culminating in an additional full dress rehearsal and private showcase performance for their family members at a concert venue.


Eligibility criteria: Inclusion Criteria for Patients:

* Aged 59 to 90 years old
* Diagnosed with dementia
* Living in the nursing home
* Interested in participating in the SOL programme
* Able to provide saliva samples

Exclusion Criteria for Patients:

* Unable to provide saliva samples

Inclusion Criteria for Psychologists:

* Aged 21 to 65 years old
* Is the psychologist of a patient who is participating in the SOL programme
* Is able to speak English

Exclusion Criteria for the Psychologists:

* Unable to complete the NPI-Q questionnaire for their patient who is participating in the SOL programme
* Decline audio recording during the focus group discussion

Primary outcomes:
measure: Changes from baseline in Oxytocin and Cortisol levels at 8 weeks
timeFrame: From the beginning of the intervention (session 1) on week 1, to the final practice session (session 8) on week 8
measure: Change from baseline in the severity and distress of neuropsychiatric symptoms at 8 weeks
timeFrame: From 2 weeks before session 1, up to the final practice session (session 8)
Secondary outcomes:
measure: Qualitative feedback
timeFrame: Within two weeks after the programme has ended
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: APEX Harmony Lodge
Study officials:
References: