Hyper-Arousal in Chronic Primary Insomnia



Status:Active, not recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 65
Updated:12/15/2016
Start Date:January 2014
End Date:February 2017

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

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.


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
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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