Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers

Completed

Conditions studied: Insomnia, Primary Insomnia, Chronic Insomnia

In brief

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.

Key facts

Study ID

NCT02290405

Run by

Jack Edinger, PhD

People needed

89

Starts

2014-10-01

Expected to finish

2017-12-31

Last updated by the study team

2021-03-30

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 sufferers who meet criteria for a comorbid sleep disorder in addition to insomnia disorder will also be excluded

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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