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The Impact of Music Intervention on Sleep

StatusRecruiting
PhaseNot applicable
Started2026-04-03
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-08-26
notable
Primary completion pushed: 2026-08-01 → 2026-12-01
2026-08-26
minor
Completion pushed: 2026-08-31 → 2026-12-31
2026-04-07
notable
Recruitment opened
Trial Details
NCT Number NCT06088810
Lead Sponsor Duke University
Collaborators: National Institute on Aging (NIA)
Conditions Dementia
Enrollment 144 participants
Start Date 2026-04-03
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-25