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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Insomnia, Primary Insomnia, Chronic Insomnia
- 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 group | Role | What 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.
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.
- First posted14 Nov 2014 (estimated)
- Study start1 Oct 2014
- Primary completion31 Oct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jack Edinger, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Jack Edinger, PhD, National Jewish Health
- Investigators
- Jack Edinger, PhD, Principal investigator, National Jewish Health
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
- ClinicalTrials.gov ID
- NCT02290405
- Acronym / sponsor ID
- 2786
- Conditions
- Insomnia, Primary Insomnia, Chronic Insomnia
- Keywords
- insomnia, primary insomnia, chronic insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Jack Edinger, PhDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Insomnia (PI) | – | Behavioral: Multiple Sleep Latency Test (MSLT)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. |
| Normal Sleepers (NS) | – | Behavioral: Multiple Sleep Latency Test (MSLT)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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Normal Sleepers (NS), Primary Insomnia (PI) |
Primary outcome
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
Number of incorrect trials during the computer-administered Attention-Switching Task test, aka Attention-Switching Task test.Attention-Switching Task Latency Error Rate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34509774Edinger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Edinger, PhD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
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.