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The Impact of Music Intervention on Sleep: CoMPoSER Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:

• 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

Locations
United States
North Carolina
Duke University School of Nursing
RECRUITING
Durham
Contact Information
Primary
Darina Petrovsky
darina.petrovsky@duke.edu
919-684-3786
Time Frame
Start Date: 2026-04-03
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 144
Treatments
Active_comparator: Sleep Education Group
Participants in this group will receive sleep education.
Experimental: CoMPoSER Intervention Group
Participants in this group will use a mobile application that plays calming music personalized for sleep enhancement.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov