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The Impact of Music Intervention on Sleep
The Impact of Music Intervention on Sleep: CoMPoSER Trial
Who can join
Ages 18 to 100 · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
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.
What is being tested
- CoMPoSER intervention group (other)
- Sleep Education (other)
Sponsor: Duke University · Participants: 144 · Started: Apr 3, 2026
Contact the study team
- Darina Petrovsky · Phone: 919-684-3786
Official record on ClinicalTrials.gov — NCT06088810
Locations in the U.S.
| North Carolina | Duke University School of Nursing, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.