The Impact of Music Intervention on Sleep
Start Date
4/3/2026
Completion Date
8/31/2026
Summary
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.
Detailed Description
Aim 1: Evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT. Aim 2: 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. Aim 3: Examine stress reduction as a mechanism of action measured via salivary cortisol by which 1-month long CoMPoSER intervention affects insomnia symptoms in PLWD. Aim 4: To determine the sustained (3 months) efficacy of CoMPoSER compared to control group on PLWD and caregiver health outcomes.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
CoMPoSER intervention group
Sleep Education
Conditions
Locations
Duke University School of Nursing
Durham, North Carolina 27710
United States