Korean J Clin Pharm.  2023 Dec;33(4):221-241. 10.24304/kjcp.2023.33.4.221.

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

• Jeon H
• Kang E
• Yoo S

• KMID: 2553203
• DOI: http://doi.org/10.24304/kjcp.2023.33.4.221

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.

Keyword

dCBT-I; digital therapeutics; efficacy; insomnia; systematic review