A Systematic Review on the Clinical Efficacy of Digital Therapeutics for Sleep Disorders: Subgroup Analysis by Control Groups

ABSTRACT

Background@# The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. @*Methods@# Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. @*Results@#Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. @*Conclusion@# The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.