AzTrials
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InsomniaNCT02290405

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

An observational study of Insomnia and Primary Insomnia, run by Jack Edinger, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Insomnia, Primary Insomnia, Chronic Insomnia
What is being tested?
Multiple Sleep Latency Test (MSLT)
How many people
89 participants
Where
1 siteUnited States
Study dates
1 Oct 2014to 31 Dec 2017
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Jewish Health

    Denver, Colorado, 80206

Other trials in United States

About this study

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.

Read the 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.

Being tested
Multiple Sleep Latency Test (MSLT)
Keywords
insomnia, primary insomnia, chronic insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple Sleep Latency Test (MSLT)Behavioural

    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 in NCT02290405
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: Behavioral: Multiple Sleep Latency Test (MSLT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2014 (estimated)
  2. Study start1 Oct 2014
  3. Primary completion31 Oct 2017
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02290405
Sponsor's protocol ID
2786
Status last verified
May 2018
First submitted
4 Nov 2014
Last updated
30 Mar 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 34509774

Questions about this trial

What is this clinical trial studying?

An observational study of Insomnia and Primary Insomnia, run by Jack Edinger, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Incorrect Trials During the Computer-administered 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.

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