Background/Purpose: Sleep disturbances are prevalent among patients with rheumatoid arthritis (RA), posing a substantial burden to patients and are intricately linked to disease activity and progression. This systematic literature review aimed to 1) identify and evaluate objective digital measures of sleep quality and quantity used in RA research and 2) aggregate present knowledge to inform endpoint selection for future clinical trials.

Methods: A comprehensive search was conducted in Embase, PubMed, and Google Scholar using broad search terms such as “rheumatoid arthritis,” “sleep stage,” “sleep parameters,” “actigraphy,” “polysomnography,” and “wearable technology.” After screening 769 titles and abstracts, 27 articles met inclusion criteria. Data extraction focused on technology used, sleep parameters measured, and correlation between objective and subjective measures.

Results: Three sleep assessment technologies were identified: Polysomnography (PSG;10 studies), wrist/leg actigraphy (16), and novel devices such as armbands and headbands (1). Of these, 8 studies had comparator control patient arms, and 5 studied improvements in sleep in the context of an intervention (e.g. initiation of a biologic therapy such as TNF inhibitors). The most commonly reported sleep parameters were sleep efficiency (SE), sleep latency, total sleep time, wake after sleep onset (WASO), fragmentation index, and number of awakenings. Multiple studies found RA patients experience poor SE (< 85%) and short sleep duration (≤6 hours) (Lee S, etal. 2020, McKenna S, etal. 2018, Katz P, etal. 2021), with 22% of patients experiencing WASO ≥90 minutes nightly (Lee S, etal. 2020). PSG studies confirmed these findings, revealing altered sleep architecture with less stage 2 sleep compared to controls (Bjurström MF, etal. 2017). Sleep disturbance was responsive to advanced therapies, with treatment trials demonstrated improved sleep quality parameters, such as reduced sleep latency and WASO, increase sleep efficiency and deep sleep, as well as sleep quantity with increased total sleep time on anti-TNF therapy (Bjurström MF, etal. 2017, Detert J, etal. 2016, Taylor-Gjevre RM, etal. 2011, Zamarrón C, etal. 2004).

Conclusion: Multiple objective sleep endpoints relevant to RA can be measured with digital technologies to enable sleep assessment. Importantly, patients with RA commonly suffer from sleep disturbance, with the potential for improvement observed in small treatment trials. Further work is needed to better quantify and qualify sleep in patients with RA receiving advanced therapies and explore mechanistic relationships.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/systematic-literature-review-of-digital-sleep-outcomes-and-endpoints-used-to-assess-rheumatoid-arthritis/