The increasing use of digital therapeutics of insomnia and other sleep disorders: a systematic review

BACKGROUND: Chronic insomnia is a significant public health problem affecting 15% of the adult population worldwide. There have been few research trials on digital therapeutics (Dtx) for insomnia and other sleep initiation and maintenance disorders (ISMD), and even less real world evaluations of their efficacy. The aim of this review is to describe the digital therapeutic (Dtx) solutions that have been reported in the scientific literature to mitigate the impact of ISMD on individuals. METHODS: We conducted a systematic review of Dtx and insomnia-related literature (with no time limits) by searching MEDLINE/Pubmed and Scopus with appropriate terms to find relevant articles. We included only primary studies and exluded those on patients with diseases other than ISMD. We extracted study characteristics such as the paper title, journal, and publication year, and we categorized them by setting of the study, type of technology/device, type of treatment provided, primary outcome, and clinical results of the Dtx use for ISMD. RESULTS: The search identified 129 articles, of which 15 full-text articles were assessed and included in the review after duplicate removal and screening. Most of the selected articles were randomized controlled trials (RTCs 60%) and real-world studies (40%) published between 2016 and 2023, and using the following types of digital technologies: mobile apps (66%), web-based programs (7%), and mixed solutions (27%). We report that these digital solutions provide digital-Cognitive Behavioural Therapy (d-CBT 67%), mindfullness (13%) and other treatments (20%). Many scientific contributions use the Insomnia Severity Index (47%) and sleep latency (20%) as primary outcomes, and all the included studies report significant improvements in ISMD control. CONCLUSIONS: Both evidence resulting from controlled trials and real-world data suggest that digital therapeutics can result in relatively high levels of engagement and clinically meaningful sleep improvements. KEY MESSAGES: • This review demonstrate that both RCTs and real-world evidence support the efficacy of digitally-provided treatments for mitigating the impact and improve outcomes of patients with insomnia. • In a ever evolving scenario, where new digital solutions and therapeutics continuously enter the market, it is mandatory to constantly monitor the efficacy and safety of such innovations.