Sing Out Loud: a Choral Singing Program for Persons Living with Dementia (SOL)

March 11, 2025 updated by: Kathleen Rose Agres, National University of Singapore

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Singing group
The intervention for the Singing group will be the 8-week SOL programme.
Other: Singing

The programme consists of nin 75-min-long singing sessions spread across 8 weeks (8 sessions are practice sessions and 1 session is a full 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.
No Intervention: Waitlist Control group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
From 2 weeks before session 1, up to the final practice session (session 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative feedback
Time Frame: Within two weeks after the programme has ended
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, they will also be asked about process factors (challenges in implementation, structure and delivery of the programme), satisfaction,
Within two weeks after the programme has ended

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Singapore

Collaborators

Esplanade
APEX Harmony Lodge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 12, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUS-IRB-2023-164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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