A Research Protocol to Develop a Prototype of a Music-Based Mobile Application to Improve Sleep in Persons Living With Dementia and Their Caregivers.

Sleep disturbances, particularly insomnia, significantly impact individuals living with Alzheimer's disease and related dementias (ADRD), leading to accelerated cognitive decline, increased institutionalization rates, and faster disease progression. While pharmacological interventions exist, their potential side effects necessitate the exploration of safer, non-pharmacological alternatives. Music interventions have shown promise in addressing sleep disturbances among older adults, yet existing solutions are neither tailored to nor extensively tested in persons living with dementia (PLWD). This study presents the research protocol for CoMPoSER (Calming Music Personalized for Sleep Enhancement in PeRsons living with Dementia), a mobile application designed specifically for PLWD and their caregivers. In the first two phases, the study will involve the development of the application and in the third phase we will employ a pilot randomized controlled trial to assess preliminary effects of the intervention and explore its mechanism of action. The research objectives include developing and refining the CoMPoSER mobile application prototype, investigating its underlying mechanisms, and evaluating its impact on both PLWD and caregiver outcomes. By developing and systematically testing approaches that address sleep disturbances in PLWD, this study aims to expand the repertoire of evidence-based interventions available to PLWD and their families, ultimately contributing to improved quality of life and disease management.