Retrospective questionnaires may miss the true impact of treatments on symptoms such as daytime functioning.
Key takeaways:
- The study involved 40 older adults with chronic insomnia randomized to suvorexant or placebo for 16 nights.
- Real-time smartphone assessments recorded four times daily detected treatment effects more powerfully than traditional recall questionnaires.
- The digital approach captured improvements in daytime symptoms including fatigue, cognitive impairment, and mood.
- Researchers suggest this method could improve evaluation for other sleep disorders like obstructive sleep apnea and excessive sleepiness.
A new study from the University of Maryland School of Medicine indicates that real-time smartphone-based assessments are more effective than traditional retrospective questionnaires at determining the effectiveness of insomnia treatments, specifically regarding daytime functioning.
Published in JAMA Network Open, the research highlights that while many treatments exist for chronic insomnia, assessing their impact on residual effects like drowsiness, cognitive issues, and irritability remains a challenge.
The clinical trial involved 40 older adults, ages 60 to 85, with chronic insomnia. Participants were randomly assigned to take the sleep medication suvorexant or a placebo for 16 nights. Both groups utilized a smartphone app to record daytime insomnia symptoms in real time, four times per day throughout the study. Additionally, participants completed traditional questionnaires assessing sleep patterns and daytime symptoms before and after treatment.
The researchers found that the smartphone-based assessment detected treatment effects more powerfully than traditional recall methods following the two-week course.
Key Findings
- Traditional questionnaires detected an overall improvement in insomnia severity between the treatment and placebo groups, but detected no significant differences in daytime symptoms.
- The smartphone-based assessment approach, called ecological momentary assessment, revealed subtle and important differences between the two groups: Compared to a placebo, suvorexant increased fatigue in the morning, but reduced fatigue in the afternoon and evening. Likewise, alert cognition was lower early in the day in the suvorexant group but normalized as the day progressed.
- Participants who took suvorexant reported numerically worse moods at all 4 times of day compared to those who took a placebo, although differences were not statistically significant.
- Participants found the smartphone assessment was easy to use, with a completion rate of 93.3% across all surveys, demonstrating feasibility and strong engagement.
“Daytime symptoms such as fatigue, cognitive impairment, and mood disturbances are core features of insomnia,” says corresponding author Emerson M Wickwire, PhD, faculty member at the University of Maryland School of Medicine and section chief of sleep medicine at the University of Maryland Medical Center, in a release. “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.”
The authors suggest that leveraging wearables and smartphones for real-time assessment should be considered for future studies evaluating treatments for insomnia and other sleep disorders, including obstructive sleep apnea.
“These findings address a critical gap in sleep disorders clinical care and research,” says Wickwire in a release. “When viewed as a complement to traditional approaches, [ecological momentary assessment] 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.”
Funding for the study was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme LLC.
