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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

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.

Condition or disease Intervention/treatment
Insomnia Primary Insomnia Chronic Insomnia Behavioral: Multiple Sleep Latency Test (MSLT)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Actual Study Start Date : October 1, 2014
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : January 1, 2018

Group/Cohort Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290405


Contacts
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Contact: Jack Edinger, PhD 303-398-1981 EdingerJ@NJHealth.org
Contact: Kelly Goelz, MA 303-398-1597 GoekzK@NJHealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jack Edinger, PhD    303-398-1981    EdingerJ@NJHealth.org   
Contact: Kelly Goelz, MA    303-398-1597    GoelzK@NJHealth.org   
Sponsors and Collaborators
Jack Edinger, PhD
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Jack Edinger, PhD National Jewish Health

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Responsible Party: Jack Edinger, PhD, Professor, Department of Medicine, National Jewish Health
ClinicalTrials.gov Identifier: NCT02290405     History of Changes
Other Study ID Numbers: 2786
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Jack Edinger, PhD, National Jewish Health:
insomnia
primary insomnia
chronic insomnia

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders