Status:
NOT_YET_RECRUITING
The Impact of Music Intervention on Sleep
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Dementia
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 Enhancemen...
Detailed Description
Aim 1: Evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT. Aim 2: Determine the impact of the mobile application CoMPoSER on PLWD (sleep latency, sleep efficiency, wake afte...
Eligibility Criteria
Inclusion
- Inclusion Criteria for persons living with dementia (PLWD):
- 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
- PLWD Exclusion Criteria:
- Hearing impairment
- Planned transition to a residential or institutional care facility in 3 months
- Presence of extrapyramidal symptoms or acute sleep disruption
- Bed bound
- Living in an alternative home setting (such as Assisted Living Community)
- Informal caregivers inclusion criteria:
- Age 18 and above.
- Providing at least 4 hours of daily care
- Living with PLWD
- Able to read and communicate in English
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06088810
Start Date
September 1 2025
End Date
August 31 2026
Last Update
June 17 2025
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