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

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ClinicalTrials.gov Identifier: NCT02290405
Recruitment Status : Unknown
Verified March 2017 by Jack Edinger, PhD, National Jewish Health.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jack Edinger, PhD, National Jewish Health

Tracking Information
First Submitted Date November 4, 2014
First Posted Date November 14, 2014
Last Update Posted Date March 29, 2017
Actual Study Start Date October 1, 2014
Estimated Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2014)
Error Rates on Performance Tests [ Time Frame: 1 day ]
Error rates on simple and complex computer administered reaction tests conducted at 2 hour interval tests across one 8 hour day of testing.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02290405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 10, 2014)
  • Mean Reaction Time [ Time Frame: 1 day ]
    Error rates on simple and complex computer administered reaction tests conducted at 2 hour interval tests across one 8 hour day of testing.
  • Correct Response Rates [ Time Frame: 1 day ]
    Error rates on simple and complex computer administered reaction tests conducted at 2 hour interval tests across one 8 hour day of testing.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Official Title Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
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 remembering.
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 contributes to reduced productivity, work and traffic accidents, and serious falls among the elderly. Despite such findings, laboratory-based efforts to corroborate the cognitive complaints of PI sufferers have produced mixed results. Indeed, many studies comparing PI sufferers with non-complaining normal sleepers across a range of neuropsychological tests have failed to show any relative deficits among the PI group. Such findings, in turn, has led to the impression that PI patients cognitive complaints may be over-stated and result from their attentional bias toward minor cognitive errors, dysfunctional beliefs about the impact of insomnia on functioning or excessive self focus rather than to any measurable daytime impairment.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This study will use a matched-groups cross-sectional experimental design. Age and gender matched groups of hyperaroused PI sufferers and non-complaining normal sleepers (NS) will be recruited and enrolled. A comprehensive screening process that includes structured sleep and psychiatric interviews, screening questionnaires, medical exam, and diagnostic PSG will be used to determine eligible subjects.
Condition
  • Insomnia
  • Primary Insomnia
  • Chronic Insomnia
Intervention Behavioral: 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.
Study Groups/Cohorts
  • 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.
    Intervention: Behavioral: Multiple Sleep Latency Test (MSLT)
  • 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.
    Intervention: Behavioral: Multiple Sleep Latency Test (MSLT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 10, 2014)
164
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2018
Estimated Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02290405
Other Study ID Numbers 2786
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jack Edinger, PhD, National Jewish Health
Study Sponsor Jack Edinger, PhD
Collaborators Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jack Edinger, PhD National Jewish Health
PRS Account National Jewish Health
Verification Date March 2017