Objective sleep outcomes in randomized-controlled trials in persons with substance use disorders: A systematic review

Background: Improving sleep health is an important target for substance use disorder (SUD) research. However, there is little guidance for SUD researchers regarding the use of technologies to objectively assess sleep outcomes in randomized-controlled trials (RCTs). This systematic review aimed to describe the use of technologies to objectively measure sleep outcomes in RCTs conducted in persons with SUDs, in order to inform future sleep intervention studies in SUD populations. Methods: This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) on May 7th, 2020 (CRD42020182004). RCTs were reviewed here if they were peer-reviewed manuscripts that included objective measures of sleep in RCTs that sought to improve sleep in persons with SUDs. Results: The initial search yielded 13,403 potential articles, with 27 meeting a priori criteria to be included in this review. The most common SUD was alcohol use disorder (59%). The most common technology used to assess sleep was polysomnography (41%), followed by actigraphy (37%), ambulatory polysomnography or components of polysomnography (e.g., electroencephalography; 19%), and at-home sleep apnea testing (7%). The most common sleep outcome reported was total sleep time (96%). Conclusions: There are a range of options to assess objective sleep outcomes. Polysomnography or ambulatory devices that directly measure brain activity are critical to advance medications through the regulatory process for the indication of improving sleep duration, continuity, and/or sleep onset latency outcomes. Actigraphy is also useful in preliminary investigations and in detecting the relationship between diurnal and SUD-related behaviors.