Actively Recruiting
The Impact of Music Intervention on Sleep
Led by Duke University · Updated on 2026-04-07
144
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary purpose of this Stage 1b NIH-funded clinical trial (K23AG073618, PI Petrovsky) is to determine the efficacy of a 1-month music intervention (Calming Music Personalized for Sleep Enhancement in PeRsons living with Dementia, CoMPoSER) on health outcomes in 72 dyads (144 participants) of persons living with dementia (PLWD) and their caregivers (Stage 1b). The secondary purpose of this research project is to examine the mechanism of stress reduction and sustained effects of the music intervention on PLWD and caregiver well-being. We will evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT and determine the impact of the mobile application CoMPoSER on PLWD (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes.
CONDITIONS
Official Title
The Impact of Music Intervention on Sleep
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persons living with dementia aged 60 and above
- Existing physician diagnosis of dementia or self-reported memory impairment with Clinical Dementia Rating Scale score greater than 0.5
- Insomnia Severity Index score above 10
- Stable dose of psychotropic medications
- Agreeing to wear an actiwatch for the study duration
- Informal caregivers aged 18 and above
- Providing at least 4 hours of daily care
- Living with person living with dementia
- Able to read and communicate in English
You will not qualify if you...
- Hearing impairment in person living with dementia
- Planned move to residential or institutional care facility within 3 months
- Presence of extrapyramidal symptoms or acute sleep disruption
- Bed bound status
- Living in alternative home setting such as Assisted Living Community
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke University School of Nursing
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
D
Darina Petrovsky
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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