Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers (NCT02290405) | Clinical Trial Compass
CompletedNot Applicable
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
United States89 participantsStarted 2014-10-01
Plain-language summary
The purpose of this study is to learn more about people with insomnia disorder and cognitive impairment. Cognitive impairment is difficulty with mental abilities such as thinking, knowing and remembering.
Who can participate
Age range
21 Years – 80 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:
* 21 to 80 years of age
* Insomnia sufferers enrolled, will meet Research Diagnostic Criteria for insomnia disorder
* score \> 14 on the Insomnia Severity Index
* report insomnia for \> 3 months
* have sleep difficulties \> 3 nights per week
* score \< 3 on the Epworth Sleepiness Scale (ESS)
* score \> 40 on the Hyperarousal Scale and report an inability to nap in the daytime
* The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score \< 10 on the ESS, score \< 35 on the Hyperarousal Scale, and deny a practice of routine daytime napping
Exclusion Criteria:
* sleep-disruptive medical condition (e.g., rheumatoid arthritis)
* current major psychiatric (Axis I) condition on the basis of a Structured Clinical Interview for Psychiatric Disorders (SCID)
* sedative hypnotic dependence and unwillingness/inability to abstain from these medications while in the study
* use of anxiolytics, antidepressants, or any other psychotropic medication
* an apnea/hypopnea index (AHI) \> 5 or a periodic limb movement-related arousal index \> 5 during on screening PSG that includes a full sleep montage to allow for detection/diagnosis of sleep-disordered breathing and Periodic Limb Movement Disorder (PLMD).
* female participants who have tested positive on urine pregnancy tests or planing on becoming pregnant during the study
* Additionally, self-described NS who meet criteria for any sleep disorder and those insomnia sufferer…
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
Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate
Timeframe: All study activities for each participant were conducted during a one-day period