Hyper-Arousal in Chronic Primary Insomnia

The University of Chicago

Status: Completed

Conditions: Chronic Insomnia

Study type: Observational

Funder types: Other

Identifiers

NCT02048878

13-1214

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

28 participants in 2 patient groups

Insomnia group

Description:

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.

Matched Control Group

Description:

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.