NCT02048878|CompletedResults
Hyper-Arousal in Chronic Primary Insomnia
Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study
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Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study
Sponsor study identifier
observational
28
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 9, 2016
Actual (reported)Study Completion
December 20, 2016
Actual (reported)The purpose of this study is to determine whether individuals with chronic insomnia disorder have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass index (BMI) and race/ethnicity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 27, 2014
Actual (reported)January 29, 2014
Actual (reported)December 9, 2016
Actual (reported)December 20, 2016
Actual (reported)January 18, 2020
Actual (reported)Sympathetic Baroreflex Sensitivity (BRS) Unit
Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.
2 months after enrollment
Systolic Arterial Pressure Reactivity
Increase in blood pressure to stress
within 2 months after enrollment
Multiple Sleep Latency Test (MSLT)
2 months of enrollment
Heart Rate Variability During Wake and During Sleep
2 months after enrollment
Electroencephalography (EEG) During Wake and Sleep
2 months of enrollment
Noninvasive Beat-to-beat Blood Pressure Monitoring
2 months after enrollment
Assessment of physiologic hyper-arousal across the two following domains: 1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness. 2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.
Assessment of physiologic hyper-arousal across the two following domains: 1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness. 2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.
Insomniacs and good sleepers
The University of Chicago
Chicago, Illinois, 60637, United States
Carter JR, Grimaldi D, Fonkoue IT, Medalie L, Mokhlesi B, Cauter EV. Assessment of sympathetic neural activity in chronic insomnia: evidence for elevated cardiovascular risk. Sleep. 2018 Jun 1;41(6):zsy048. doi: 10.1093/sleep/zsy048.
Eve Van Cauter, PhD
University of Chicago
Babak Mokhlesi, MD
University of Chicago
Jason R Carter, PhD
Michigan Technological University
28 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2014
First Posted
January 29, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of Chronic Hypnotic Use 2
Contact the study team to confirm eligibility.
Primary Completion
December 9, 2016
Actual (reported)Study Completion
December 20, 2016
Actual (reported)Last Updated
January 18, 2020
Results First Posted
January 18, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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