Hyper-Arousal in Chronic Primary Insomnia

Completed

• Conditions: Chronic Insomnia

• Registration Number: NCT02048878
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Primary Completion: 2016-12-09
• Study Completion: 2016-12-20
• Results First Submitted: 2019-04-15
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-03
• Last Update Submitted: 2020-01-03
• Results First Posted: 2020-01-18
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic Arterial Pressure Reactivity	within 2 months after enrollment	Increase in blood pressure to stress
Sympathetic Baroreflex Sensitivity (BRS) Unit	2 months after enrollment	Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.

Secondary Outcome Measures

Name	Time	Method
Multiple Sleep Latency Test (MSLT)	2 months of enrollment	MSLT will be used to objectively quantify tendency to fall asleep (sleep latency).
Heart Rate Variability During Wake and During Sleep	2 months after enrollment	The balance between sympathetic and parasympathetic nervous control of the heart will be determined by spectral analysis of heart rate variability using continuous electrocardiogram (ECG) recording for 24 hours, including the normal sleep period.
Electroencephalography (EEG) During Wake and Sleep	2 months of enrollment	The EEG will be measured continuously during sleep and at frequent intervals during wake. The signal will be submitted to power spectral analysis to examine spectral power in frequency bands that are typical of arousal and in frequency bands that are typical of deep sleep.
Noninvasive Beat-to-beat Blood Pressure Monitoring	2 months after enrollment

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States