Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes (NCT05908526) | Clinical Trial Compass
CompletedPhase 2
Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
United States40 participantsStarted 2023-10-09
Plain-language 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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder.
* Insomnia Severity Index total score \>10.
* Insomnia symptoms must include problems with wake after sleep onset.
* Insomnia symptom duration \> 6 months.
* Baseline self-reported total sleep time \< 6.5 hours per night.
Exclusion Criteria:
* High risk for untreated organic sleep disorders other than insomnia (narcolepsy, periodic limb movement disorder, etc) as determined by structured clinical interview and investigator clinical judgment.
* Current diagnosis of a major untreated psychiatric disorder(s).
* History of serious suicide attempt within past 5 years.
* History of alcohol or substance abuse (including prescription medication abuse) within past 5 years.
* Heavy alcohol consumption (e.g., \>5 drinks per day or \> 14 drinks per week.
* Heavy caffeine use \[(\>2 cups of coffee/day (equivalent).
* Current tobacco or nicotine use.
* History of previous allergic reaction, sensitivity, or severe side effects to sedative hypnotics.
* CYP3A inhibitors.
* Refusal to discontinue or intention to initiate OTC or other sleep aids during study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Daytime Insomnia Symptoms Scale (DISS)
Timeframe: Baseline (start of study) and end of study (before day 16).
2
Change in Insomnia Severity as Assessed by Insomnia Severity Index
Timeframe: Baseline (start of study) and end of study (before day 16).