The Impact of Music Intervention on Sleep: CoMPoSER Trial
Duke University
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.
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 outc…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- Yes
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 alternati…
Interventions
- OtherCoMPoSER intervention group
Participants in the intervention will use a mobile application that plays calming music personalized for sleep enhancement, relaxation techniques and nighttime routine guidance.
- OtherSleep Education
Participants in this intervention will receive sleep education based on the NIH/NIA guide, which includes tips for getting a good night's sleep.
Location
- Duke University School of NursingDurham, North Carolina