Hyper-Arousal in Chronic Primary Insomnia

Chronic Insomnia Clinical Trial

Official title:

Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048878
• Other study ID #: 13-1214
• Status: Completed
• Start date: January 2014
• Est. completion date: December 20, 2016

Study information

• Verified date: January 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 20, 2016
• Est. primary completion date: December 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria for Insomniacs:

• Men and women with primary insomnia of at least 3 months in duration

• ages 21-65 years old

• BMI <35 kg/m2 to enable microneurography

• Moderate to severe insomnia based on the Insomnia Severity Index (ISI) questionnaire

• Pittsburgh Sleep Quality Index (PSQI) > 5

• Self-reported habitual sleep duration < 6.5 hours

Inclusion criteria for good sleepers:

• 21-65 years old men and women with BMI <35 kg/m2

• No insomnia based on ISI questionnaire

• Self-reported habitual sleep duration = 6.5 hours but < 9 hours

• PSQI<5

• Sleep efficiency on PSG with TRT of 8 hours > 85%

• No history of mental illness, shift work, circadian rhythm disorders

Exclusion criteria for both insomniacs and good sleepers:

• Sleep disorders other than insomnia as assessed by screening PSG (apnea-hypopnea index or AHI = 10, PLM arousal index = 5)

• Circadian rhythm sleep disorders

• Diabetic based on HbA1c = 6.5 %. For those with HbA1c = 6.0 but <6.5%, the non-diabetic condition will be confirmed by 2-h oral glucose tolerance test

• History of meeting DSM-IVR criteria based on the Mini International Neuropsychiatric Interview version 6.0 for any major psychiatric disorder

• Unstable or serious medical conditions

• Current, or use within the past month, of psychoactive (other than stable treatment with antidepressants), hypnotic, stimulant or analgesic medications (except occasional non-narcotic analgesics), beta blockers or alpha blockers

• Shift work or other types of self imposed irregular sleep schedules

• Habitual smoking

• Habitual alcohol consumption

• Pregnancy

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Systolic Arterial Pressure Reactivity	Increase in blood pressure to stress	within 2 months after enrollment
Secondary	Multiple Sleep Latency Test (MSLT)	MSLT will be used to objectively quantify tendency to fall asleep (sleep latency).	2 months of enrollment
Secondary	Heart Rate Variability During Wake and During Sleep	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.	2 months after enrollment
Secondary	Electroencephalography (EEG) During Wake and Sleep	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.	2 months of enrollment
Secondary	Noninvasive Beat-to-beat Blood Pressure Monitoring		2 months after enrollment