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 range21 Years – 80 Years
SexALL
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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…
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