144 Participants NeededMy employer runs this trial

Music Intervention for Dementia

DP
Overseen ByDarina Petrovsky
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
Must be taking: Psychotropic medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called CoMPoSER, which plays calming music to help people with dementia and their caregivers sleep better and feel less stressed. Researchers aim to determine if listening to personalized music at bedtime improves sleep and well-being for both groups. People with dementia who have trouble sleeping, along with their caregivers who live with them and provide daily support, might be a good fit for this study.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep and reduce stress for many.

Will I have to stop taking my current medications?

The trial requires that participants with dementia stay on a stable dose of their current psychotropic medications.

What prior data suggests that the CoMPoSER music intervention is safe for persons living with dementia?

Research has shown that music activities, such as using the CoMPoSER app, are generally safe for people with dementia. Studies have found that music therapy can lift mood, reduce anxiety, and lessen agitation in older adults with dementia, without causing major side effects. For example, organized music sessions significantly calmed agitation and anxiety. Additionally, music therapy has been linked to improved thinking skills and does not increase the likelihood of participants leaving studies. These findings suggest that music as a therapy tool is well-tolerated and safe for individuals with dementia.12345

Why are researchers excited about this trial?

Researchers are excited about the Music Intervention for Dementia trial because it explores a unique, non-pharmacological approach to improving sleep in dementia patients. Unlike traditional treatments that often rely on medications with potential side effects, this trial uses CoMPoSER, a mobile app that delivers calming, personalized music to enhance sleep. This innovative method could offer a safer, more accessible alternative for managing sleep disturbances in dementia without the need for medication. The trial also includes a Sleep Education Group, which provides participants with valuable insights into sleep hygiene, potentially empowering them with practical knowledge to improve their sleep quality.

What evidence suggests that the CoMPoSER music intervention is effective for dementia?

Research has shown that music therapy can enhance thinking skills and quality of life for people with dementia. Studies have found that structured music activities significantly reduce restlessness and anxiety in older adults with dementia. Music therapy also addresses sleep problems, which are common in this population. In this trial, participants in the CoMPoSER Intervention Group will use a mobile application that plays personalized calming music to aid sleep by making it easier to fall asleep, stay asleep, and achieve better overall rest. Overall, music therapy offers a promising non-drug treatment for various dementia symptoms.25678

Who Is on the Research Team?

DP

Darina Petrovsky

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for people aged 60 or older with dementia or memory problems who have trouble sleeping, are on stable medication, and can wear a sleep-tracking watch. It excludes those moving to care facilities soon, living in assisted settings, with severe movement issues, major sleep disruptions, hearing loss, or who are bedbound.

Inclusion Criteria

I am 60 years old or older.
Score of >10 on the Insomnia Severity Index
Existing physician diagnosis of dementia or self-reported memory impairment and Clinical Dementia Rating Scale score of greater than 0.5
See 2 more

Exclusion Criteria

Planned transition to a residential or institutional care facility in 3 months
Living in an alternative home setting (such as Assisted Living Community)
I have movement problems or trouble sleeping suddenly.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the CoMPoSER mobile application for a 1-month music intervention aimed at improving sleep and reducing stress

4 weeks
1 visit (in-person) for baseline assessment, ongoing virtual monitoring

Follow-up

Participants are monitored for sustained effects of the intervention on sleep and stress outcomes

3 months
1 visit (in-person) at 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • CoMPoSER

Trial Overview

The study compares a personalized calming music app (CoMPoSER) designed to improve sleep in people with dementia against standard sleep education. Both the person with dementia and their caregiver participate over one month.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CoMPoSER Intervention GroupExperimental Treatment1 Intervention
Group II: Sleep Education GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

Investigating Music Therapy's Cognitive Benefits in Patients ...

Numerous previous studies have shown the effectiveness of music therapy in enhancing cognitive functions in patients with dementia.

The effects of music interventions on behavioural and ...

This study provides new evidence demonstrating that structured music intervention significantly reduces agitation and anxiety in older adults with dementia. The ...

Music and Dementia: An Overview - - Practical Neurology

Recent findings suggest that that musical training delays cognitive decline and promotes brain plasticity in the elderly brain. More studies are ...

Music Therapy in the Treatment of Dementia: A Systematic ...

After meta-analysis, it was shown that the intervention with music improves cognitive function in people living with dementia, as well as quality of life after ...

NCT06088810 | The Impact of Music Intervention on Sleep

Compared to PLWD in the sleep education control group, PLWD in the CoMPoSER intervention will experience improved insomnia symptoms of sleep latency, sleep ...

The promise of music therapy for Alzheimer's disease: A review

Effects of MT in patients with AD include improved mood, reduced depressive scores and trait anxiety, enhanced autobiographical recall, verbal fluency, and ...

CoMPoSER, Developing a Music-Based Sleep App for ...

Recent studies reveal that music interventions may show promise to address sleep disturbances that most patients with dementia experience ...

Music Therapy in the Treatment of Dementia: A Review Article

The study reported that musicians were 64% less likely to develop mild cognitive impairment (MCI) or dementia. The impact of these ...