A recent study by the University of Maryland School of Medicine suggests that using real-time smartphone assessments can help measure how well sleep medications work for people with chronic insomnia. The research, published in JAMA Network Open, involved 40 adults between the ages of 60 and 85 who took either suvorexant or a placebo for 16 nights. Participants used a smartphone app to report their daytime symptoms such as fatigue and mood four times each day during the trial.
The researchers found that this approach detected treatment effects more clearly than traditional recall questionnaires. According to Emerson M. Wickwire, PhD, corresponding author of the study and section chief of sleep medicine at the University of Maryland Medical Center, "Daytime symptoms such as fatigue, cognitive impairment, and mood disturbances are core features of insomnia. Improving sleep is not enough. We need to determine how well treatments improve daytime functioning, which patients report matters most. In this study we found that retrospective questionnaires failed to detect subtle treatment-related changes that were detected via the smartphone assessment."
This was reportedly the first randomized controlled trial to use a smartphone ecological momentary assessment (EMA) as an outcome measure in a sleep-focused clinical trial. Researchers observed that EMA could identify clear treatment effects at different times during the day and was both easy to use and sustainable over time.
Dr. Wickwire added, "These findings address a critical gap in sleep disorders clinical care and research. When viewed as a complement to traditional approaches, EMA offers a sensitive and patient-centered way to measure treatment effects throughout the day, in real-time. Such approaches could transform how we evaluate sleep treatments, personalize sleep medicine care, and ultimately improve outcomes for the millions of Americans with sleep disorders."
Other contributors included Shuo Chen, PhD; Avelino Verceles, MD; and graduate student Jingsong Zhou from UMSOM. The project received partial funding from Merck Sharp & Dohme LLC.
UMSOM Dean Mark T. Gladwin commented on the broader implications: "This research underscores the potential for innovative digital tools to be used in conducting comparative effectiveness studies," he said. "Smartphone-based assessments can provide real-time insights that help improve patient outcomes across a range of common conditions."