Insomnia is a highly prevalent condition that significantly degrades the quality of life and health of millions ofpatients. By diagnostic definition, insomnia is a disease characterized by self-reported subjective criteria, thustherapeutic developers targeting insomnia typically evaluate their treatment's efficacy based on patient reportedoutcomes in the form of sleep diaries. A critical flaw with this assessment approach is that self-perception ofsleep is inherently noisy due to the inability of patients to perceive the transition to and from unconscious sleepand sources of variability related to bias, mood, and other contextual factors. To overcome this limitation, manyclinical trials incorporate clinically validated wearable devices into their trials as surrogate assessments whichare interpreted in conjunction with sleep diary data. Wearable devices are also imperfect tools to assess sleepbecause they are similarly limited by non-disease, non-treatment related factors including imperfect operation,imperfect algorithms, and misuse. Furthermore, numerous studies in clinical and non-clinical populations havedemonstrated that there are significant discrepancies between sleep diaries and wearable device derived sleepmetrics raising the question as to which assessment approach is valid. Without a method to reconcile differencesbetween sleep diaries and wearable devices the current practice for clinical trials is to rely on sleep diary datawhich is suboptimal and may contribute to blunted or nonsignificant effects in trials. The improved patientreported outcome (iPRO) - Sleep Diary is a method and system designed to improve sleep assessment bycombining sleep diary and wearable device data while maintaining the subjectivity of sleep assessment. Theproposed solution is to provide patients their wearable device-derived sleep data contemporaneously with thecompletion of the sleep diary. The patient reported sleep diary measurement is still the outcome of interest,however patients have the freedom to incorporate or disregard their objective data in their assessment. Thisapproach is inspired by signal processing theory where measurements from two sensors with uncorrelatedsources of error (sleep diary and wearable device) are combined to improve the measurement of the underlyingsignal. The approach of providing patients their objective data and then using their sleep diary response (incontrast to averaging) is used to preserve patient autonomy and leverage the benefits of self-reported data.Preliminary data suggest the iPRO-Sleep Diary non-linearly improves measurement precision of sleep metricsand reduces discrepancy between device and sleep diary data. This platform technology is expected to improvethe assessment of sleep in clinical trials and enable more efficient development of effective therapeutics.
Public Health Relevance Statement: Project Narrative
Insomnia is a highly prevalent disorder with significant health and economic impacts. Unfortunately, the
development of therapeutics for insomnia is hindered by suboptimal sleep assessment in clinical trials. This
project proposes to further develop the improved patient reported outcome (iPRO) - Sleep Diary, a platform
technology, to improve sleep assessment and to optimize therapeutic development for insomnia.
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