N/A N=89

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

Insomnia · Primary Insomnia · Chronic Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT02290405 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate — 5.11; 3.1 trials

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Multiple Sleep Latency Test (MSLT) (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Jack Edinger, PhD
Primary completion: Oct 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.