664 Characteristics of respondents to a virtual trial of a digital behavioral treatment for insomnia during the COVID-19 pandemic

Introduction: Rates of sleep disturbance and sleep medication use have increased during the COVID-19 pandemic, at a time when face-to-face delivery of behavioral insomnia treatments is severely limited. To support research during the pandemic, the FDA released guidelines promoting the use of “alternative methods” to conduct trials in a virtual or decentralized manner. Currently, few data exist regarding the impact of virtual trial enrollment during a pandemic. This abstract presents data from a decentralized, open-label, single-arm real-world clinical trial of the Somryst prescription digital therapeutic for insomnia, which provides insight on who seeks care for insomnia using virtual research methods. Methods: In alignment with FDA guidance, the DREAM trial began enrolling patients in March, 2020 with an expected final sample size of 350 adults (Clinical Trial # NCT04325464). This abstract presents data from participants seeking enrollment into the trial via an online screening. Demographic and sleep variables were collected to confirm eligibility. Results: Of 1,063 respondents, the majority were female (62%) and the most common age brackets were ages 30-39 (22%);40-49 (20%);and 50-59 (20%). Most respondents (63.8%) did not report being under the care of a healthcare provider for their insomnia. Respondents reported sleep problems for an average of 12.9 years;sleep problems 5 nights/week;and sleeping an average of 5.4 hours/night. Geographic diversity was high with respondents from 45 states and Washington DC. Of those passing initial screening (N=270), 5.5% reported having another diagnosed sleep disorder, 14.4% reported a comorbid psychological condition, 58.9% reported taking a medication for insomnia, and 30.7% reported taking a medication for depression. Using the Insomnia Severity Index, 16.7% had subthreshold/mild insomnia (score 8-14), 60.0% had moderate insomnia (score 15-21), and 23.7% had severe insomnia (score > 21). Conclusion: Respondents to this decentralized trial reported moderate-severe, long-lasting insomnia with high rates of medication use for sleep and depression. Results demonstrate that virtual trials can quickly draw a highly geographically diverse research population, overcoming logistical challenges inherent in a pandemic and resulting in recruiting appropriate, but more geographically diverse, samples than those typically observed in randomized trials of cognitive behavioral therapy for insomnia (CBT-I).