Hyper-Arousal in Chronic Primary Insomnia

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Insomnia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insomnia group<br>Assessment of physiologic hyper-arousal across the two following domains: 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. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis. | |
| Matched Control Group<br>Assessment of physiologic hyper-arousal across the two following domains: 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. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sleep Latency Test (MSLT) | MSLT will be used to objectively quantify tendency to fall asleep (sleep latency). | 2 months of enrollment | 
| 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 | 
| 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 | 
| Noninvasive Beat-to-beat Blood Pressure Monitoring |  | 2 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia