DementiaSOLNCT06880237
Sing Out Loud: A Choral Singing Program for Persons Living With Dementia
A study testing Singing in people with Dementia and Nursing Homes Residents, run by National University of Singapore at 1 site in Singapore.
Trial summary
This study intends 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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Nursing Homes Residents
- What is being tested?
- Singing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Mar 2025to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Aged 21 to 65 years old
- Is the psychologist of a patient who is participating in the SOL programme
- Is able to speak English
Who cannot join
- Unable to provide saliva samples
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study intends 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:
- 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?
- 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).
Read more
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.
- Conditions
- Dementia, Nursing Homes Residents
- Being tested
- Singing
- Keywords
- Dementia, Nursing Home Residents, Singing, Biomarkers, NPI-Q
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SingingOther
The programme consists of one 75-min-long group singing session per week for 8 weeks, followed by a dress rehearsal and a final performance. The final rehearsal session and showcase performance will be held at a concert venue, while the 8 practice sessions will be conducted at the nursing home.
Each session will kick off with a "Hello song", followed by warm-up activities and vocal exercises. Participants will then sing different songs to explore and rehearse as a group, before concluding with a "Goodbye song". All sessions throughout the programme are similarly structured to provide consistency for participants.
| Study group | Role | What they receive |
|---|---|---|
| Singing group | Experimental | The intervention for the Singing group will be the 8-week SOL programme. Receives: Other: Singing |
| Waitlist Control group | No intervention | The Waitlist Control group will not receive any intervention during the course of the study but will receive the SOL programme in its next iteration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Oxytocin and Cortisol levels at 8 weeks
Oxytocin and Cortisol levels will be collected via saliva samples. Increases in level of Oxytocin is indicative of increased feelings of social connection, while increased level of Cortisol is indicative of higher levels of stress
Measured: From the beginning of the intervention (session 1) on week 1, to the final practice session (session 8) on week 8
Change from baseline in the severity and distress of neuropsychiatric symptoms at 8 weeks
Neuropsychiatric symptoms will be collected via the Neuropsychiatric Inventory Questionnaire (NPI-Q), which measures delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, motor disturbance, nightime behaviours, and appetite. Higher scores indicate increased levels of severity or distress related to the symptom in question.
Measured: From 2 weeks before session 1, up to the final practice session (session 8)
Secondary outcomes (1)
Qualitative feedback
This will be collected via a focus group discussion with the nursing home's clinical staff (psychosocial team) to collect qualitative data on any observed changes in participants' mood, behaviour, temperament, or relationships between participants and staff. Additionally, the nursing home's psychosocial team will also be asked about process factors (challenges in implementation, structure and delivery of the programme), satisfaction,
Measured: Within two weeks after the programme has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start12 Mar 2025
- Primary completion26 May 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Esplanade, APEX Harmony Lodge
- Responsible party
- Principal investigator, Kathleen Rose Agres, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880237
- Sponsor's protocol ID
- NUS-IRB-2023-164
- Acronym
- SOL
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sing Out Loud: A Choral Singing Program for Persons Living With Dementia
- ClinicalTrials.gov ID
- NCT06880237
- Acronym / sponsor ID
- SOL / NUS-IRB-2023-164
- Conditions
- Dementia, Nursing Homes Residents
- Keywords
- Dementia, Nursing Home Residents, Singing, Biomarkers, NPI-Q
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Esplanade, APEX Harmony Lodge
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends 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:
- 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?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Singing group | Experimental | Other: SingingThe intervention for the Singing group will be the 8-week SOL programme. |
| Waitlist Control group | No intervention | –The Waitlist Control group will not receive any intervention during the course of the study but will receive the SOL programme in its next iteration. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide saliva samples
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SingingThe programme consists of one 75-min-long group singing session per week for 8 weeks, followed by a dress rehearsal and a final performance. The final rehearsal session and showcase performance will be held at a concert venue, while the 8 practice sessions will be conducted at the nursing home. Each session will kick off with a "Hello song", followed by warm-up activities and vocal exercises. Participants will then sing different songs to explore and rehearse as a group, before concluding with a "Goodbye song". All sessions throughout the programme are similarly structured to provide consistency for participants. | Other | Singing group |
Primary outcome
Changes from baseline in Oxytocin and Cortisol levels at 8 weeks
Time frame: From the beginning of the intervention (session 1) on week 1, to the final practice session (session 8) on week 8
Oxytocin and Cortisol levels will be collected via saliva samples. Increases in level of Oxytocin is indicative of increased feelings of social connection, while increased level of Cortisol is indicative of higher levels of stress
Change from baseline in the severity and distress of neuropsychiatric symptoms at 8 weeks
Time frame: From 2 weeks before session 1, up to the final practice session (session 8)
Neuropsychiatric symptoms will be collected via the Neuropsychiatric Inventory Questionnaire (NPI-Q), which measures delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, motor disturbance, nightime behaviours, and appetite. Higher scores indicate increased levels of severity or distress related to the symptom in question.
1 secondary outcome
Qualitative feedback
Time frame: Within two weeks after the programme has ended
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing in people with Dementia and Nursing Homes Residents, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Oxytocin and Cortisol levels at 8 weeks (time frame: From the beginning of the intervention (session 1) on week 1, to the final practice session (session 8) on week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.