People with Alzheimers Disease and Related Dementias (ADRDs) often experience Circadian Activity Rhythm (CAR) disruption, which is characterized by a loss of strong, stable, 24-hour sleep- wake behavioral patterns. CAR disruption correlates with lower quality of life in people with ADRDs, and another CAR pattern is linked with depression symptoms in family caregivers. Despite the health relevance of CARs, there are no products on the consumer or medical markets to measure them; as a result, CAR disruption is under-detected and seldom managed in practice. Popular consumer wearable devices contain accelerometers that could be leveraged to provide a widely-usable, passive system for objective CAR monitoring. But current platforms use activity data to infer absolute levels of sleep and activity (separately), and do not provide validated measures of their patterning or CAR disruption (i.e., rhythm stability, shape, fragmentation, and timing). We propose to fill this gap with a new digiceutical platform designed to work across existing wearables: the Circadian Activity Profiling System (CAPS). The CAPS provides patients, their caregivers, and their clinicians with real-time CAR monitoring. Our overarching goal is to enable the personalization and adaptive tailoring of interventions that address CAR disruption to reduce related health consequences. Towards this end, we propose a Phase I Small Business Technology Transfer project to validate this technology and evaluate user-acceptance in people with ADRDs and their caregivers (n=30 dyads). We assembled a team with expertise in health effects of CARs (Dr. Smagula, PI), sleep/circadian medicine (Dr. Hall, Pitt PI), geriatric patient care (Dr. Patira, Co-I and Dr. Vahia, consultant), and digital health technology (Mr. Dancy and Mr. Ward). Aim 1 will solidify raw-data extraction routines on the Apple Watch and expand to FitBit (Aim 1a); and validate the CAPS against gold-standard research-grade accelerometers (Aim 1b). Criteria for success in Aim 1 are: successfully syncing at least 95% of epochs; and achieving excellent (?0.9) intraclass correlation coefficient of the CAPS against the gold-standard. Aim 2 will gather objective user acceptance data, pre-/post- quality of life measures, conduct focus groups with users, and interview clinicians. For Aim 2, success will be defined via a synthesis of evidence across key areas: evidence of user-adherence on par with existing medical treatments (i.e., >70%); evidence that the monitoring system alone has effects on health measures; and input from clinician-stakeholders regarding how they foresee using the CAPS in practice. We expect that this Phase I project will generate evidence guiding the development of a Phase II proposal for a randomized trial evaluating the clinical utility of the CAPS in terms of improving important health outcomes relevant to families affected by dementia. If, instead, we find that the CAPS is unacceptable to ADRD users or in clinical practice, validating a passive CAR monitoring solution could still have a public health/market impact, since patterns of CAR disruption also can mark/drive risk for suicidality, cancer death, and mortality in general. Public Health Relevance Statement
Project narrative: Circadian Activity Rhythm (CAR) disruption is highly prevalent in people with dementia, lowering quality of life for patients and caregivers alike. This proposal is to develop, validate, and perform user-acceptability testing of the worlds first, user-friendly, wearable system for assessing and monitoring CARs. If successful, this project will set the stage for a clinical trial testing a new digital tool that allows providers to precisely target and tailor circadian-based interventions to reduce the adverse effects of circadian disruption in families affected by dementia.
