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Search / Trial NCT06088810

The Impact of Music Intervention on Sleep

Launched by DUKE UNIVERSITY · Oct 12, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Dementia

ClinConnect Summary

This clinical trial is studying the effects of a special music program designed to help improve sleep for people living with dementia and their caregivers. Over the course of one month, 72 pairs of participants (a person with dementia and their caregiver) will use a mobile app called CoMPoSER, which plays calming music tailored to enhance sleep. The researchers want to see if this music intervention helps improve sleep quality for both the person with dementia and their caregiver, as well as reduce stress for the caregiver.

To be eligible for this study, participants with dementia need to be at least 60 years old and have a doctor’s diagnosis of dementia, along with some specific sleep issues. They should also be stable on their medications and agree to wear a device that tracks their sleep patterns. Caregivers must be at least 18 years old, live with the person they care for, and provide a minimum of four hours of care each day. The trial is not yet recruiting participants, but it aims to explore how music can positively impact the well-being of both individuals involved.

Gender

ALL

Eligibility criteria

  • 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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Patients applied

0 patients applied

Trial Officials

Darina Petrovsky

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported