Personalized calming music to improve sleep for people living with dementia and their caregivers
The Impact of Music Intervention on Sleep: CoMPoSER Trial
This project will try a personalized mobile music app to help people with dementia sleep better and to reduce caregiver stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06088810 on ClinicalTrials.gov |
What this trial studies
This is a pilot randomized controlled trial enrolling 72 caregiver–person with dementia dyads to test a one-month personalized calming music mobile app called CoMPoSER versus sleep education. Outcomes measured in people living with dementia include sleep latency, sleep efficiency, wake after sleep onset, total sleep time, and sleep quality using actigraphy and questionnaires, while caregivers complete measures of perceived stress and well-being. The study will also measure salivary cortisol to explore whether stress reduction explains sleep changes and will follow participants for three months to determine sustained effects. The trial is NIH-funded and conducted at Duke University School of Nursing.
Who should consider this trial
Good fit: Ideal candidates are people living with dementia aged 60 or older who have insomnia symptoms (Insomnia Severity Index >10), live with an informal caregiver who provides at least four hours of daily care, are willing to use a mobile app and wear an actiwatch, and whose caregiver can communicate in English.
Not a fit: Patients with significant hearing impairment, those who are bed bound, living in assisted living or planning a move to institutional care within three months, or those with acute extrapyramidal symptoms or severe sleep disruption are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the app could improve sleep for people with dementia and reduce stress and improve well-being for their caregivers using a low-burden home intervention.
How similar studies have performed: Prior small studies of music interventions have shown benefits for sleep and behavioral symptoms in dementia, but a personalized mobile app with cortisol-based mechanism testing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for persons living with dementia (PLWD): * Age 60 and above * Existing physician diagnosis of dementia or self-reported memory impairment and Clinical Dementia Rating Scale score of greater than 0.5, * Score of \>10 on the Insomnia Severity Index * Stable dose of psychotropic medications * Agreeing to wear an actiwatch for the duration of the study PLWD Exclusion Criteria: * Hearing impairment * Planned transition to a residential or institutional care facility in 3 months * Presence of extrapyramidal symptoms or acute sleep disruption * Bed bound * Living in an alternative home setting (such as Assisted Living Community) Informal caregivers inclusion criteria: * Age 18 and above. * Providing at least 4 hours of daily care * Living with PLWD * Able to read and communicate in English
Where this trial is running
Durham, North Carolina
- Duke University School of Nursing — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Darina Petrovsky — Duke University
- Study coordinator: Darina Petrovsky
- Email: darina.petrovsky@duke.edu
- Phone: 919-684-3786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.