Hyper-Arousal in Chronic Primary Insomnia
2020年1月3日 更新者:University of Chicago
Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study
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.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
28
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60637
- The University of Chicago
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Insomniacs and good sleepers
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
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:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Sympathetic Baroreflex Sensitivity (BRS) Unit
大体时间:2 months after enrollment
|
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
大体时间:within 2 months after enrollment
|
Increase in blood pressure to stress
|
within 2 months after enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Multiple Sleep Latency Test (MSLT)
大体时间:2 months of enrollment
|
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
大体时间: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.
|
2 months after enrollment
|
Electroencephalography (EEG) During Wake and Sleep
大体时间: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.
|
2 months of enrollment
|
Noninvasive Beat-to-beat Blood Pressure Monitoring
大体时间:2 months after enrollment
|
2 months after enrollment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Eve Van Cauter, PhD、University of Chicago
- 首席研究员:Babak Mokhlesi, MD、University of Chicago
- 首席研究员:Jason R Carter, PhD、Michigan Technological University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (实际的)
2016年12月9日
研究完成 (实际的)
2016年12月20日
研究注册日期
首次提交
2014年1月27日
首先提交符合 QC 标准的
2014年1月27日
首次发布 (估计)
2014年1月29日
研究记录更新
最后更新发布 (实际的)
2020年1月18日
上次提交的符合 QC 标准的更新
2020年1月3日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.