Status:
COMPLETED
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Lead Sponsor:
Jack Edinger, PhD
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Insomnia
Primary Insomnia
Eligibility:
All Genders
21-80 years
Brief 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 remember...
Detailed Description
Primary insomnia (PI) sufferers typically complain of such daytime impairments as reduced attention, concentration, memory and global mental acuity. Moreover, epidemiological studies have shown PI con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02290405
Start Date
October 1 2014
End Date
December 31 2017
Last Update
March 30 2021
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206