Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT02290405
Eligibility Criteria:
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 sufferers who meet criteria for a comorbid sleep disorder in addition to insomnia disorder will also be excluded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02290405
Study Brief:
Protocol Section:
NCT02290405