Chronic Insomnia
Conditions
Keywords
Insomnia
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.
Interventions
None listed
Sponsors
University of Chicago
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sympathetic Baroreflex Sensitivity (BRS) Unit | 2 months after enrollment | Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode. |
| Systolic Arterial Pressure Reactivity | within 2 months after enrollment | Increase in blood pressure to stress |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sleep Latency Test (MSLT) | 2 months of enrollment | MSLT will be used to objectively quantify tendency to fall asleep (sleep latency). |
| Heart Rate Variability During Wake and During Sleep | 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. |
| Electroencephalography (EEG) During Wake and Sleep | 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. |
| Noninvasive Beat-to-beat Blood Pressure Monitoring | 2 months after enrollment | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insomnia Group 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. | 13 |
| Matched Control Group 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. | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Insomnia Group | Matched Control Group | Total |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 15 | 35 years STANDARD_DEVIATION 13 | 37.3 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Sympathetic Baroreflex Sensitivity (BRS) Unit
Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.
Time frame: 2 months after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insomnia Group | Sympathetic Baroreflex Sensitivity (BRS) Unit | -2.1 bursts per 100 heart beats per mm Hg | Standard Deviation 1 |
| Matched Control Group | Sympathetic Baroreflex Sensitivity (BRS) Unit | -4.3 bursts per 100 heart beats per mm Hg | Standard Deviation 1.3 |
Primary
Systolic Arterial Pressure Reactivity
Increase in blood pressure to stress
Time frame: within 2 months after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insomnia Group | Systolic Arterial Pressure Reactivity | 21 mmHg | Standard Deviation 11 |
| Matched Control Group | Systolic Arterial Pressure Reactivity | 14 mmHg | Standard Deviation 8 |
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.
Time frame: 2 months of enrollment
Population: 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.
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.
Time frame: 2 months after enrollment
Population: 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.
Secondary
Multiple Sleep Latency Test (MSLT)
MSLT will be used to objectively quantify tendency to fall asleep (sleep latency).
Time frame: 2 months of enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insomnia Group | Multiple Sleep Latency Test (MSLT) | Nap 2 | 7.3 minutes | Standard Deviation 7.2 |
| Insomnia Group | Multiple Sleep Latency Test (MSLT) | Nap 4 | 6.7 minutes | Standard Deviation 5.7 |
| Insomnia Group | Multiple Sleep Latency Test (MSLT) | Nap 3 | 6.8 minutes | Standard Deviation 6.9 |
| Insomnia Group | Multiple Sleep Latency Test (MSLT) | Nap 5 | 12.7 minutes | Standard Deviation 7.1 |
| Insomnia Group | Multiple Sleep Latency Test (MSLT) | Nap 1 | 8.7 minutes | Standard Deviation 6.8 |
| Matched Control Group | Multiple Sleep Latency Test (MSLT) | Nap 5 | 8.4 minutes | Standard Deviation 7.1 |
| Matched Control Group | Multiple Sleep Latency Test (MSLT) | Nap 1 | 11.2 minutes | Standard Deviation 8.2 |
| Matched Control Group | Multiple Sleep Latency Test (MSLT) | Nap 2 | 9.4 minutes | Standard Deviation 6.1 |
| Matched Control Group | Multiple Sleep Latency Test (MSLT) | Nap 3 | 5.3 minutes | Standard Deviation 3.2 |
| Matched Control Group | Multiple Sleep Latency Test (MSLT) | Nap 4 | 6.5 minutes | Standard Deviation 6.4 |
Secondary
Noninvasive Beat-to-beat Blood Pressure Monitoring
Time frame: 2 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insomnia Group | Noninvasive Beat-to-beat Blood Pressure Monitoring | Systolic Blood Pressure dipping | 7.3 mm Hg | Standard Deviation 11.9 |
| Insomnia Group | Noninvasive Beat-to-beat Blood Pressure Monitoring | Diastolic Blood Pressure dipping | 3.0 mm Hg | Standard Deviation 5.9 |
| Matched Control Group | Noninvasive Beat-to-beat Blood Pressure Monitoring | Systolic Blood Pressure dipping | 15.2 mm Hg | Standard Deviation 7.3 |
| Matched Control Group | Noninvasive Beat-to-beat Blood Pressure Monitoring | Diastolic Blood Pressure dipping | 6.4 mm Hg | Standard Deviation 2.5 |