Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Significant differences between groups - HRV
研究概览
简要总结
Post-traumatic stress disorder (PTSD) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. A psychiatric diagnosis of PTSD is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. Discernable patterns of stress-related measures may constitute a physiological and biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans.
The current study is aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD. Physiological and biochemical data will be collected from participants with and without PTSD using wearable sensors and adhesive biosensor patches. The data will be collected in two conditions: in a neutral, quiet situation, and during and following exposure to controlled stressogenic stimuli.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PTSD diagnosis (excluding controls)
- •Proper ability to give informed consent
排除标准
- •Active oncological/cardiovascular condition
- •Dialysis patients
- •Active psychotic or suicidal symptoms
- •Severe dissociative symptoms
- •A traumatic brain injury (TBI) diagnosis
- •Pregnancy
研究组 & 干预措施
Pariticapnts with PTSD
干预措施: Stressogenic stimulus (Behavioral)
Pariticapnts with PTSD
干预措施: Biobeat smart watch and adhesive biosensor patches. (Device)
Pariticapnts without PTSD (controls)
干预措施: Stressogenic stimulus (Behavioral)
Pariticapnts without PTSD (controls)
干预措施: Biobeat smart watch and adhesive biosensor patches. (Device)
结局指标
主要结局
Significant differences between groups - HRV
时间窗: 3 hours
Significant differences in Heart Rate Variability - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - temperature
时间窗: 3 hours
Significant differences in physiological changes - body temperature- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - SPO2
时间窗: 3 hours
Significant differences in physiological changes - Saturation SPO2- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - blood pressure
时间窗: 3 hours
Significant differences in physiological changes - continuous blood pressure- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - pulse pressure
时间窗: 3 hours
Significant differences in physiological changes - pulse pressure - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups -respiratory rate
时间窗: 3 hours
Significant differences in physiological changes - respiratory rate- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups -stroke volume
时间窗: 3 hours
Significant differences in physiological changes - stroke volume- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups -cardiac output
时间窗: 3 hours
Significant differences in physiological changes - cardiac output - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - systemic vascular resistance
时间窗: 3 hours
Significant differences in physiological changes - systemic vascular resistance- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in cortisol levels between groups
时间窗: 3 hours
Significant differences in biochemical changes - cortisol - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - C-reactive protein
时间窗: 3 hours
Significant differences in biochemical changes - C-reactive protein - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - Interleukin 6
时间窗: 3 hours
Significant differences in biochemical changes - Interleukin 6 - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide
时间窗: 3 hours
Significant differences in biochemical changes - N-terminal B-type natriuretic peptide - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - 8-oxo-7
时间窗: 3 hours
Significant differences in biochemical changes - 8-oxo-7- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine
时间窗: 3 hours
Significant differences in biochemical changes - 8-dihydro-2'-deoxyguanosine - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - hexanone
时间窗: 3 hours
Significant differences in biochemical changes - hexanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - acetic acid
时间窗: 3 hours
Significant differences in biochemical changes - acetic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - heptane
时间窗: 3 hours
Significant differences in biochemical changes - heptane - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - hexanal
时间窗: 3 hours
Significant differences in biochemical changes -hexanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - 3-heptanone
时间窗: 3 hours
Significant differences in biochemical changes - 3-heptanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - hexanoic acid
时间窗: 3 hours
Significant differences in biochemical changes - hexanoic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - heptanal
时间窗: 3 hours
Significant differences in biochemical changes -heptanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - nonanal
时间窗: 3 hours
Significant differences in biochemical changes - nonanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - glucose
时间窗: 3 hours
Significant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
次要结局
未报告次要终点
研究者
Nadav Goldental
Principal investigator
The Chaim Sheba Medical Center