The Impact of Music Intervention on Sleep

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06088810
Status
Recruiting
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Conditions

  • Dementia

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • CoMPoSER intervention group — OTHER
    Participants in the intervention will use a mobile application that plays calming music personalized for sleep enhancement, relaxation techniques and nighttime routine guidance.
  • Sleep Education — OTHER
    Participants in this intervention will receive sleep education based on the NIH/NIA guide, which includes tips for getting a good night's sleep.

Study Details

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.

Key Dates

Start date
Apr 3, 2026
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Acceptability [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University School of NursingDurhamNorth Carolina27710
Darina Petrovsky
[email protected]
919-681-7041

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By research site
Duke University School of Nursing· Durham, NC

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