Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
NCT ID: NCT02290405
Last Updated: 2021-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
89 participants
OBSERVATIONAL
2014-10-01
2017-12-31
Brief Summary
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Detailed Description
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However, many previous such studies were underpowered due to small sample sizes and employed neuropsychological tests designed for detecting impairment resulting from brain disease/damage rather than the more subtle albeit significant impairments of which PI patients complain. In recent research, we and others have shown that PI sufferers do, indeed, show greater deficits (slower and more variable reaction times) particularly on complex switching attention tasks. Moreover, there is some preliminary evidence that the subgroup of PI sufferers with elevated levels of physiological hyperarousal are most prone to suffer from neuro-cognitive performance deficits than are matched groups of PI sufferers who are not physiologically hyperaroused and normally alert individuals without insomnia. For example, Fernandez-Mendoza recently showed that PI sufferers with a hyperarousal pattern suggested by their objective short sleep duration on serial polysomnograms (PSG) performed more poorly on a complex switching attention task than did both normal sleepers and PI sufferers with normal objective sleep durations.
In our efforts to follow up on this latter work, we recently examined the error rates of alert and sleepy PI sufferers and normal sleepers across a series of simple and complex reaction time tasks. We employed age and gender matched samples of PI (N=89) sufferers and normal sleepers-NS (N=95). Participants underwent three nights of PSG followed by daytime testing with a four-trial Multiple Sleep Latency Test-MSLT. The PI and NS groups were each subdivided into "alert" (e.g., MSLT mean onset latency \> 8 minutes) and "sleepy" (e.g., MSLT mean onset latency \< 8 minutes) subgroups to allow for testing the main and interaction effects of participant type and level of alertness. "Alert" participants had longer MSLT latencies than "sleepy" participants (12.7 vs. 5.4 minutes). PI sufferers had fewer correct responses on performance testing than did NS. However, as shown by the adjacent, figure we found a significant group x alertness interaction (p = .0013) with greater error rates occurring among alert (hyperaroused) PI sufferers (Mean=4.5±3.6 errors per trial) than among alert NS (Mean=2.6±1.9 errors per trial). This was particularly true for the more complex switching attention task.
Our work along with that of Fernandez-Mendoza serve to confirm that PI sufferers have measureable objective neuro-cognitive deficits and provide some preliminary suggestion for the types of testing approaches that should be used to detect them. The identification of tests sensitive to PI sufferers' cognitive deficits are particularly relevant for testing the effects of current and future insomnia therapies on patients' objective daytime functioning. Measures of daytime dysfunction can and should serve as endpoints for assessing benefits and detriments of insomnia therapies. In addition, our recent work suggests that subgroups of PI sufferers may differ in their daytime deficits, with those showing physiological hyperarousal being most prone to make errors. This finding suggests that different types or doses of treatment may be needed to reverse the daytime impairments of the hyperaroused and non-aroused PI patients. However, our line of research would benefit by replication and extension findings to (1) further confirm the detrimental effects of physiological hyperarousal on PI sufferer's neuro-cognitive functioning; and (2) identify a broader range of tests that can be used for assessing diurnal cognitive impairments in both physiologically hyperaroused and lesser aroused PI groups. The current project will address these aims.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Primary Insomnia (PI)
PI 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 Scale10 and report an inability to nap in the daytime.
Multiple Sleep Latency Test (MSLT)
The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists.
Normal Sleepers (NS)
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 Scale10, and deny a practice of routine daytime napping.
Multiple Sleep Latency Test (MSLT)
The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists.
Interventions
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Multiple Sleep Latency Test (MSLT)
The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
80 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Jack Edinger, PhD
OTHER
Responsible Party
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Jack Edinger, PhD
Professor, Department of Medicine
Principal Investigators
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Jack Edinger, PhD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Locations
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National Jewish Health
Denver, Colorado, United States
Countries
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References
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Edinger JD, Bathgate CJ, Tsai S, Khassawneh B. Impact of daytime sleepiness and insomnia on simple and complex cognitive task performances. Sleep Med. 2021 Nov;87:46-55. doi: 10.1016/j.sleep.2021.08.004. Epub 2021 Aug 12.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2786
Identifier Type: -
Identifier Source: org_study_id
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