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

NCT02290405 | Completed Results

• 1 other identifier: 2786
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Primary Insomnia; Chronic Insomnia

Keywords

insomnia; primary insomnia; chronic insomnia

Outcome Measures

Primary Outcomes (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

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

Study Arms (2)

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)

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)

Interventions

Multiple Sleep Latency Test (MSLT) BEHAVIORAL

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); Primary Insomnia (PI)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jack Edinger, PhD: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

• 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.

  PMID: 34509774 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Bryan Simmons
• Organization: National Jewish Health

SimmonsB@NJHealth.org

303-398-1850

Study Officials

• Jack Edinger, PhD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Medicine

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2018-05

Locations

US (1)