Study Finds Smartphone Assessments Effective for Evaluating Sleep Treatment

Approximately one in nine adults experience chronic insomnia, resulting in symptoms such as drowsiness, cognitive difficulties, and irritability, along with increased health risks like diabetes and heart disease if not treated. A new study from the University of Maryland School of Medicine indicates that real-time smartphone assessments can effectively evaluate the effectiveness of sleep medications by measuring improvements in daytime symptoms of insomnia.

The study, published in JAMA Network Open, involved 40 older adults, ages 60 to 85, diagnosed with chronic insomnia. Participants were randomly assigned to receive suvorexant, a sleep medication, or a placebo for 16 nights. Using a smartphone app, participants recorded their daytime insomnia symptoms four times daily. They also completed traditional questionnaires assessing sleep patterns and daytime symptoms before and after treatment.

While traditional questionnaires detected an overall improvement in insomnia severity between the treatment and placebo groups, they did not reveal significant differences in daytime symptoms. In contrast, the smartphone-based ecological momentary assessment (EMA) identified nuanced differences: suvorexant increased fatigue in the morning but reduced it later in the day. Alertness was lower earlier in the day for those on suvorexant but normalized throughout the day. Furthermore, although participants taking suvorexant reported slightly worse mood throughout the day compared to those on placebo, these differences were not statistically significant.

Participants rated the smartphone assessment as user-friendly, achieving a 93.3% completion rate, highlighting its feasibility and engagement.

“Daytime symptoms such as fatigue, cognitive impairment, and mood disturbances are core features of insomnia,” said study lead author Emerson M. Wickwire, PhD, from the University of Maryland School of Medicine. “Improving sleep is important, but it’s equally essential to assess how well treatments enhance daytime functioning, which is what patients often prioritize. Our findings suggest that traditional questionnaires may miss subtle, treatment-related changes that can be captured through smartphone assessments.”

This study is the first randomized controlled trial to utilize smartphone EMA as an outcome measure in sleep research, effectively capturing treatment effects at various times of the day. Researchers propose that integrating wearables and smartphones for real-time assessments could be beneficial in future studies on insomnia and other sleep disorders.

Dr. Wickwire highlighted that these findings address significant gaps in the clinical care and research of sleep disorders. When used alongside traditional assessment methods, EMA offers a sensitive, patient-centered approach to quantify treatment effects throughout the day. This could enhance how sleep treatments are evaluated, tailored, and ultimately improve outcomes for millions of Americans suffering from sleep issues.

Co-authors of the study include Shuo Chen, PhD, Avelino Verceles, MD, MS, and graduate student Jingsong Zhou, MS. Funding was partially supported by a grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme LLC.

UMSOM Dean Mark T. Gladwin, MD, emphasized the potential of digital tools in enhancing comparative effectiveness studies, noting that smartphone assessments can provide real-time insights to improve patient outcomes across various health conditions.