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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insomnia group | Assessment of physiologic hyper-arousal across the two following domains:
| ||
| Matched Control Group | Assessment of physiologic hyper-arousal across the two following domains:
|
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| 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 |
| 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 |
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Inclusion Criteria for Insomniacs:
Inclusion criteria for good sleepers:
Exclusion criteria for both insomniacs and good sleepers:
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Insomniacs and good sleepers
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| Name | Affiliation | Role |
|---|---|---|
| Eve Van Cauter, PhD | University of Chicago | Principal Investigator |
| Babak Mokhlesi, MD | University of Chicago | Principal Investigator |
| Jason R Carter, PhD | Michigan Technological University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29522186 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insomnia Group | Assessment of physiologic hyper-arousal across the two following domains:
|
| FG001 | Matched Control Group | Assessment of physiologic hyper-arousal across the two following domains:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insomnia Group | Assessment of physiologic hyper-arousal across the two following domains:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sympathetic Baroreflex Sensitivity (BRS) Unit | Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode. | Posted | Mean | Standard Deviation | bursts per 100 heart beats per mm Hg | 2 months after enrollment |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insomnia Group | Assessment of physiologic hyper-arousal across the two following domains:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eve Van Cauter, PhD | University of Chicago | 773-702-0169 | evcauter@bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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 |
| BG001 | Matched Control Group | Assessment of physiologic hyper-arousal across the two following domains:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Assessment of physiologic hyper-arousal across the two following domains:
|
|
|
| Primary | Systolic Arterial Pressure Reactivity | Increase in blood pressure to stress | Posted | Mean | Standard Deviation | mmHg | within 2 months after enrollment |
|
|
|
| Secondary | Multiple Sleep Latency Test (MSLT) | MSLT will be used to objectively quantify tendency to fall asleep (sleep latency). | One insomnia subject and one good sleeper control could not remain in the laboratory for the entire duration of the test due to personal scheduling issues. | Posted | Mean | Standard Deviation | minutes | 2 months of enrollment |
|
|
|
| Secondary | 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. | The biological signals were recorded but not submitted to the labor-intensive spectral analysis due to end of funding. Summary data were not generated. Therefore, no results on this outcome can be reported. | Posted | 2 months after enrollment |
|
|
| Secondary | 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. | The biological signals were recorded but not submitted to the labor-intensive spectral analysis due to end of funding. Summary data were not generated. Therefore, no results on this outcome can be reported. | Posted | 2 months of enrollment |
|
|
| Secondary | Noninvasive Beat-to-beat Blood Pressure Monitoring | Two insomnia subjects and 3 control subjects dropped out of the study after completing their first inpatient visit due to scheduling conflicts related to their professional occupation. | Posted | Mean | Standard Deviation | mm Hg | 2 months after enrollment |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Matched Control Group | Assessment of physiologic hyper-arousal across the two following domains:
| 0 | 12 | 0 | 12 |
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| D001523 |
| Mental Disorders |
| Nap 3 |
|
| Nap 4 |
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| Nap 5 |
|