N/A
N=28
Hyper-Arousal in Chronic Primary Insomnia
Chronic Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT02048878 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Sympathetic Baroreflex Sensitivity (BRS) Unit — -2.1; -4.3 bursts per 100 heart beats per mm Hg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sympathetic Baroreflex Sensitivity (BRS) Unit |
-2.1; -4.3 | — |
| PRIMARY Systolic Arterial Pressure Reactivity |
21; 14 | — |
| SECONDARY Multiple Sleep Latency Test (MSLT) |
8.7; 11.2; 7.3; 9.4; 6.8; 5.3 | — |
| SECONDARY Heart Rate Variability During Wake and During Sleep |
— | — |
| SECONDARY Electroencephalography (EEG) During Wake and Sleep |
— | — |
| SECONDARY Noninvasive Beat-to-beat Blood Pressure Monitoring |
7.3; 15.2; 3.0; 6.4 | — |
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 5
- Self-reported habitual sleep duration 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
Data sourced from ClinicalTrials.gov (NCT02048878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.