At a glance
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The Impact of Suvorexant on Cognitive Function and Daytime Symptoms Among Community-dwelling Older Adults With Insomnia: A Placebo-controlled, Randomized Clinical Trial Using Remote Monitoring and Ecological Momentary Assessment
In Brief
A Phase 2 clinical trial evaluating Baseline surveys, Cognitive testing and EMAs, Actiwatch, and 2 other interventions for Insomnia. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. The primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. The word "placebo" refers to a harmless pill with no therapeutic effect.
Study Details
Timeline
Interventions
Outcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and cognitive testing administered by computer.
Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.
FDA approved which is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
An inactive substance that looks like the drug or treatment being tested.