NCT06880237

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. 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 17, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

March 11, 2025

Last Update Submit

March 11, 2025

Conditions

Keywords

DementiaNursing Home ResidentsSingingBiomarkersNPI-Q

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    From 2 weeks before session 1, up to the final practice session (session 8)

Secondary Outcomes (1)

  • Qualitative feedback

    Within two weeks after the programme has ended

Study Arms (2)

Singing group

EXPERIMENTAL

The intervention for the Singing group will be the 8-week SOL programme.

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.

Interventions

SingingOTHER

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.

Singing group

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APEX Harmony Lodge

Singapore, Singapore, 518240, Singapore

Location

MeSH Terms

Conditions

Dementia

Interventions

Singing

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhonationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Kathleen R Agres, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

March 12, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

March 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations