NCT06088810 · RECRUITING
The Impact of Music Intervention on Sleep
This trial is testing a personalized music app called CoMPoSER, designed to play calming music at bedtime to help people living with dementia sleep better. Researchers are also measuring caregiver stress and well-being. It is a Phase NA pilot randomized controlled trial — meaning this is an early-stage test of whether the approach works and whether people find the app acceptable to use.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-07