CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
suvorexant (or placebo) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05908526
NCT05908526Phase 2Completed

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

University of Maryland, Baltimore·interventional·Posted Jun 18, 2023·Updated Oct 30, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States

Timeline

Phase 2CompletedFinished
202420252026
First PostedJun 18, 2023
Enrollment StartOct 9, 2023
Primary CompletionAug 8, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.0 years ago

Interventions

Baseline surveys, Cognitive testing and EMAsbehavioral

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.

Actiwatchdevice

Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.

suvorexant (or placebo)drug

FDA approved which is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Placeboother

An inactive substance that looks like the drug or treatment being tested.