Recruiting

CoMPoSER

Sponsor:

Duke University

Code:

NCT06088810

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

CoMPoSER intervention group

Sleep Education

Study Details

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 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.

Conditions

Dementia

Study ID

NCT06088810

Start date

Apr 3, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Acceptability [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Darina Petrovsky

919-684-3786darina.petrovsky@duke.edu

Locations

Duke University School of Nursing

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Darina Petrovsky

9196817041PetrovskyResearch@duke.edu

More Information

Sponsor

Duke University

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-25.