Clinical trial NCT02048878: Hyper-Arousal in Chronic Primary Insomnia
Official title: Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Insomnia
Keywords: Insomnia
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Insomniacs and good sleepers

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.


Eligibility 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

Primary outcomes:
measure: Sympathetic Baroreflex Sensitivity (BRS) Unit
timeFrame: 2 months after enrollment
measure: Systolic Arterial Pressure Reactivity
timeFrame: within 2 months after enrollment
Secondary outcomes:
measure: Multiple Sleep Latency Test (MSLT)
timeFrame: 2 months of enrollment
measure: Heart Rate Variability During Wake and During Sleep
timeFrame: 2 months after enrollment
measure: Electroencephalography (EEG) During Wake and Sleep
timeFrame: 2 months of enrollment
measure: Noninvasive Beat-to-beat Blood Pressure Monitoring
timeFrame: 2 months after enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Eve Van Cauter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Babak Mokhlesi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Technological University
name: Jason R Carter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carter JR, Grimaldi D, Fonkoue IT, Medalie L, Mokhlesi B, Cauter EV. Assessment of sympathetic neural activity in chronic insomnia: evidence for elevated cardiovascular risk. Sleep. 2018 Jun 1;41(6):zsy048. doi: 10.1093/sleep/zsy048.