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RECRUITING
NCT06088810
NA

The Impact of Music Intervention on Sleep

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: The Impact of Music Intervention on Sleep: CoMPoSER Trial

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2026-04-03

Completion Date

2026-08-31

Last Updated

2026-04-07

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

CoMPoSER 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.

OTHER

Sleep 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.

Locations (1)

Duke University School of Nursing

Durham, North Carolina, United States