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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02290405
Enrollment
89
Registered
2014-11-14
Start date
2014-10-01
Completion date
2017-12-31
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Insomnia, Insomnia, Primary Insomnia

Keywords

insomnia, primary insomnia, chronic insomnia

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.

Interventions

BEHAVIORALMultiple 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.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Jack Edinger, PhD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error RateAll study activities for each participant were conducted during a one-day periodNumber of incorrect trials during the computer-administered Attention-Switching Task test, aka Attention-Switching Task test.Attention-Switching Task Latency Error Rate

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
36
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.
53
Total89

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicPrimary Insomnia (PI)Normal Sleepers (NS)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants1 Participants4 Participants
Age, Categorical
Between 18 and 65 years
33 Participants52 Participants85 Participants
Age, Continuous40.6 years
STANDARD_DEVIATION 14.1
31.5 years
STANDARD_DEVIATION 10.5
35.1 years
STANDARD_DEVIATION 12.8
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants5 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants48 Participants82 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants4 Participants
Race (NIH/OMB)
More than one race
1 Participants4 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
32 Participants46 Participants78 Participants
Region of Enrollment
United States
36 Participants53 Participants89 Participants
Sex: Female, Male
Female
26 Participants37 Participants63 Participants
Sex: Female, Male
Male
10 Participants16 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 53
other
Total, other adverse events
0 / 360 / 53
serious
Total, serious adverse events
0 / 360 / 53

Outcome results

Primary

Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate

Number of incorrect trials during the computer-administered Attention-Switching Task test, aka Attention-Switching Task test.Attention-Switching Task Latency Error Rate

Time frame: All study activities for each participant were conducted during a one-day period

ArmMeasureValue (MEAN)
Primary Insomnia (PI)Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate5.11 trials
Normal Sleepers (NS)Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate3.1 trials

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026