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OpenTrials
Completed

NCT Number: NCT02048878

Hyper-Arousal in Chronic Primary Insomnia

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sympathetic Baroreflex Sensitivity (BRS) Unit

    Time frame: 2 months after enrollment

    Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.

  2. Systolic Arterial Pressure Reactivity

    Time frame: within 2 months after enrollment

    Increase in blood pressure to stress

Secondary outcomes

  1. Multiple Sleep Latency Test (MSLT)

    Time frame: 2 months of enrollment

    MSLT will be used to objectively quantify tendency to fall asleep (sleep latency).

  2. Heart Rate Variability During Wake and During Sleep

    Time frame: 2 months after enrollment

    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.

  3. Electroencephalography (EEG) During Wake and Sleep

    Time frame: 2 months of enrollment

    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.

  4. Noninvasive Beat-to-beat Blood Pressure Monitoring

    Time frame: 2 months after enrollment

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2014
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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