The Impact of Music Intervention on Sleep

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 1, 2026 → Dec 1, 2026
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Record History

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  1. Re-verified, no change to tracked fields
  2. Enrollment closed, study ongoing Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised
    • Publications: details revised at 6 of 6 entries
  3. Primary completion pushed from Aug 1, 2026 to Dec 1, 2026
    • Study completion pushed from Aug 31, 2026 to Dec 31, 2026
    • Site contact updated
    v9
  4. Recruitment opened
    • Start date changed from estimate of Apr 1, 2026 to Apr 3, 2026
    v8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 1, 2026 to Apr 1, 2026
    • Study sites: 0 to 1
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Sep 1, 2025 to Feb 1, 2026v6
  2. Start date: Apr 1, 2025 to Sep 1, 2025
    • Study completion date: Aug 1, 2026 to Aug 31, 2026
    v5
  3. Start date: Jan 1, 2025 to Apr 1, 2025v4
  4. Re-verified, no change to tracked fieldsv3
  5. Lead sponsor: Rutgers, The State University of New Jersey to Duke University
    • Start date: Jun 1, 2024 to Jan 1, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Duke University
457 trials monitored
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Dementia
1,982 trials monitored
See 105 trials at risk
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.
Trial Details
NCT Number NCT06088810
Lead Sponsor Duke University
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)		 Dementia
Related terms Dementia
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov