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Orexin Antagonist
Sleeping Pill for Insomnia
Phase 2
Recruiting
Led By Emerson M Wickwire, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (start of study) and end of study (before day 16).
Awards & highlights
Summary
This trial examines the effect of a sleeping pill on daytime symptoms in older adults with insomnia. It compares the pill to a harmless placebo.
Who is the study for?
This trial is for older adults who meet the criteria for insomnia disorder, have trouble staying asleep, and sleep less than 6.5 hours per night. Participants should not be heavy drinkers or caffeine users, allergic to sedative hypnotics, using certain inhibitors or other sleep aids, tobacco users, have major untreated psychiatric disorders or a history of substance abuse.
What is being tested?
The study tests suvorexant against a placebo to see if it improves sleep and daytime symptoms like cognition and mood in those with insomnia. It involves baseline surveys, cognitive testing with EMAs (real-time assessments), taking suvorexant or placebo pills, and wearing an Actiwatch to monitor activity.
What are the potential side effects?
Suvorexant may cause drowsiness during the day, headaches, dizziness when standing up too quickly from sitting or lying down position (orthostatic hypotension), abnormal dreams or nightmares; side effects can vary between individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (start of study) and end of study (before day 16).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (start of study) and end of study (before day 16).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Daytime Insomnia Symptoms Scale (DISS)
Secondary study objectives
Change in Cognitive Performance Assessed by the PVT (psychomotor vigilance test)
Change in Cognitive Performance Assessed by the Stroop test
Change in Cognitive Performance Assessed by the Task-switching
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment3 Interventions
Participants will start on 10mg suvorexant, po, qhs, including instructions on dosage, expectations, and potential side effects, for two nights. Following this low-dose run-in period, individuals in the treatment condition will be increased to 20mg for a 14-day active treatment period (i.e.,16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing (completed at baseline and post-treatment), as well as EMA surveys, daily sleep diaries, and actigraphy.
Group II: PlaceboPlacebo Group3 Interventions
Participants in the control condition will take placebo (no drug) pill form, po, qhs, including instructions on dosage, expectations, and potential side effects for (16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing, daily sleep diaries, and actigraphy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Actiwatch
2022
N/A
~180
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
705 Previous Clinical Trials
378,410 Total Patients Enrolled
1 Trials studying Insomnia
30 Patients Enrolled for Insomnia
Merck Sharp & Dohme LLCIndustry Sponsor
3,956 Previous Clinical Trials
5,175,223 Total Patients Enrolled
20 Trials studying Insomnia
3,509 Patients Enrolled for Insomnia
Emerson M Wickwire, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had trouble sleeping for more than 6 months.I am at high risk for sleep disorders other than insomnia, as confirmed by a doctor.I often wake up and have trouble falling back asleep.I am not taking any medications that affect my liver's ability to process drugs.I will not start or stop any over-the-counter sleep aids during the study.You have been diagnosed with insomnia disorder according to the DSM-5 guidelines.Your score on the Insomnia Severity Index is higher than 10.I have had trouble sleeping for more than 6 months.I often wake up and have trouble falling back asleep.You usually sleep less than 6.5 hours per night.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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