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

SUBMITTER: Thorndike F 

PROVIDER: S-EPMC8135640 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature