A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk

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Summary Our long-term goal is to improve healthcare with non-pharmacological interventions that use the science of behavior change and new Internet of Things (IoT) devices to augment clinical treatment. When you go to the doctor of the future, instead of prescribing a drug, in many cases the doctor may prescribe a software intervention guiding the patient through a process of facilitated behavior change and environmental optimization. This software approach to healthcare addresses the high-priority of providing services to individuals with limited/no access to care and for addressing the public health issues of insomnia and conversion to Mild Cognitive Impairments (MCI) and Alzheimer's Disease (AD). These diseases are thought to cost the US Healthcare system more than $400 billion/year, with another $400 billion/year cost to U.S. businesses in lost productivity, sick days, and accidents. In our Phase I, we were the first research group to show that non-phase locked auditory stimulation can improve next day performance on attention measures without adversely impacting sleep organization, quality, or total sleep time. Our acoustic intervention increased the percentage and intensity of slow-wave sleep (SWS), the stage of sleep with many regenerative properties and which typically decreases with age. We have additional preliminary evidence that this sound-based intervention, played at the right time and volume during sleep, can enhance next day memory performance. Due to the accumulating support demonstrating the role that sleep quality and SWS play in conversion to MCI and AD from imaging studies, longitudinal studies, and cognitive assessments, our intervention may address both the public health issue of poor sleep quality and AD. In our Phase II, we propose to further address insomnia and AD risk by integrating our deep sleep enhancement intervention and sound masking intervetinos with additional IoT devices, such as the FitBit, Apple Watch, and Oura Ring for more accurately measuring sleep and delivering sleep improvement enhancements, such as smart light bulbs to entrain and strengthen circadian rhythms, and Amazon's Alexa to deliver relaxation interventions and reminders to address compliance. The developed software will include a sleep diary with all relevant sleep statistics viewable by a trained therapist in the gold standard treatment for insomnia, cognitive behavioral therapy for insomnia (CBTi). Displaying this data to the clinician can be used to deliver more personalized interventions and increase compliance with the treatment. We propose to conduct a randomized clinical trial on 65+ aged healthy individuals in an independent living facility that have symptoms for insomnia and compare our enhanced type of CBTi integrated with new IoT technology to typical CBTi and a passive control of sleep hygiene therapy. We hypothesize that our intervention is just as effective as the gold standard treatment for insomnia of CBTi as measured by sleep efficiency on a sleep diary (primary outcome). The system may also have the additional benefit of improving next day cognitive performance (secondary outcome), a meaningful indicator of cognitive decline and AD risk. Exploratory analyses further test the effects of the intervention on a neurodegeneration biomarker panel and additional cognitive performance measures.