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

Abstract

Abstract 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). Support (if any):