N/A
Completed N=89
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Source: ClinicalTrials.gov NCT02290405 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate — 5.11; 3.1 trials
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate |
5.11; 3.1 | — |
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 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 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
Data sourced from ClinicalTrials.gov (NCT02290405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.