Pharmacological Prevention of Post-traumatic Intrusions in Healthy Volunteers - Towards a Post-exposition Prophylaxis for Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- EEG measures of sleep quality: sleep onset latency
研究概览
简要总结
In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. The quantity of intrusive memories of the trauma will be compared between the three conditions.
详细描述
The present study seeks to investigate the potential to pharmacologically modulate slow-wave sleep in the acute aftermath of an experimentally-induced trauma in the interest of developing a secondary prevention of posttraumatic stress disorder. The effects of a GABAergic compound will be compared with that of a noradrenergic compound. Memory, sleep and stress-related immune response factors will be quantified and compared across drug conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Speaks and understands German
- •BMI 18.5 -< 25
- •Non-smoker status
- •Habitual 5 or fewer alcoholic beverages / week
- •Habitual 3 or fewer caffeinated beverages / day
- •Habitual average sleep duration 7-9 h / night
- •Normal or corrected-to-normal vision
- •Insomnia Severity Index score between 8-14
排除标准
- •Travel across 3 or more time zones within 3 months of study start
- •Habitual napping
- •Extreme chronotype, determined by Morningness-Eveningness Questionnaire
- •History of or presence of a trauma- or stressor-related disorder
- •History of or presence of neurological disorder, psychiatric disorder or head injury
- •History of or presence of a sleep disorder
- •History of or presence of cardiovascular disorder
- •Use of illicit drugs
- •Atypical preference for excessively violent portrayals
- •Faints at the site of blood or brutality
- •Has participated in a study < 30 days or a study such as this (i.e., experimental trauma) at all.
研究组 & 干预措施
Dexmedetomidine
Sublingual dose of dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
Sublingual dose of dexmedetomidine
干预措施: Placebo (Drug)
Dexmedetomidine
Sublingual dose of dexmedetomidine
干预措施: Experimental Model Trauma Film (Behavioral)
Gamma-hydroxybutyrate
Oral dose of gamma-hydroxybutyrate
干预措施: Gamma-Hydroxybutyrate (Drug)
Gamma-hydroxybutyrate
Oral dose of gamma-hydroxybutyrate
干预措施: Placebo (Drug)
Gamma-hydroxybutyrate
Oral dose of gamma-hydroxybutyrate
干预措施: Experimental Model Trauma Film (Behavioral)
Placebo
Oral (saline) and sublingual (orodispersible tablet) doses
干预措施: Dexmedetomidine (Drug)
Placebo
Oral (saline) and sublingual (orodispersible tablet) doses
干预措施: Placebo (Drug)
Placebo
Oral (saline) and sublingual (orodispersible tablet) doses
干预措施: Experimental Model Trauma Film (Behavioral)
结局指标
主要结局
EEG measures of sleep quality: sleep onset latency
时间窗: Four nights, each night a week apart, spanning one month
Sleep onset latency represents elapsed time from intention to initiate sleep until sleep is initiated (defined as the occurrence of any stage of sleep by the AASM). Longer latencies indicate lower homeostatic sleep pressure or some maladaptive, e.g., rumination, stress, or pathological state, e.g., insomnia, posttraumatic stress. Normal latencies for healthy adults is 10 - 20 minutes.
EEG measures of sleep quality: sleep efficiency
时间窗: Four nights, each night a week apart, spanning one month
Sleep efficiency represents how efficient a given sleep episode is and is defined as the duration of sleep (i.e., time spent in all NREM and REM sleep stages) divided b by the total time spent in bed and multiplied by 100. Normal sleep efficiency is 80% or greater. Efficiencies less than this value could raise questions of sleep satiety, maladaptive behavior (e.g., alcohol consumption, caffeine consumption, sleep at incongruent circadian phase) or pathological health conditions (e.g., restless legs, disordered breathing, insomnia).
Personal significance of intrusive memories
时间窗: Three weeks
Personal significance of intrusive memories will be recorded in a diary after experiencing an intrusive memory in an integer scale. The integer scale will range from 1 to 10, where 1 indicates the lowest and 10 indicates the highest.
Oscillatory theta power in the sleep electroencephalogram (EEG) during non rapid eye movement sleep stages N2 and N3
时间窗: Four nights, each night a week apart, spanning one month
Power in units microvolts squared will be quantified by fast Fourier transform in 4 second segment length in EEG sleep recordings in the theta frequency bin (6 - 9 Hz). Higher value of theta power indicates greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
Emotional valence of intrusive memories
时间窗: Three weeks
The emotional valence will be recorded in a diary after experiencing an intrusive memory in an integer scale. The integer scale will range from 1 to 10, where 1 indicates the lowest and 10 indicates the highest.
Oscillatory delta power in the sleep electroencephalogram (EEG) during non rapid eye movement (REM) sleep stages N2 and N3
时间窗: Four nights, each night a week apart, spanning one month
Power in units microvolts squared will be quantified by fast Fourier transform in 4 second segment length in EEG sleep recordings in the delta frequency bin (0.5 - 4.5 Hz).Higher value of delta power indicates greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
EEG measures of sleep quality: distribution of N2 and N3 sleep stages.
时间窗: Four nights, each night a week apart, spanning one month
Number of non-REM sleep stages N2 and N3. Greater number of stages N2 and N3 indicate greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
Frequency of intrusive memories
时间窗: Three weeks
The number of intrusive memories of the experimental model trauma film experienced. The number of intrusive memories will be recorded in a diary by participants.
EEG measures of sleep quality: number of arousals
时间窗: Four nights, each night a week apart, spanning one month
Number of arousals Arousals are defined by the American Academy of Sleep Medicine as an increase in EEG frequency at least 3 seconds in NREM sleep in alpha, theta or higher frequencies, excluding spindles; must be accompanied by a minimum of 1 second of muscle activity during REM sleep. The greater the number of arousals indicates the lower homeostatic sleep pressure is in healthy individuals. Normal number of arousals for a healthy adult is ca. 80 per 8 hour sleep episode.
EEG measures of sleep quality: sleep duration
时间窗: Four nights, each night a week apart, spanning one month
Sleep duration represents the duration in time of a sleep episode excluding any intervening stages of waking. Typical sleep duration in the healthy adult population is ca. 8 hours. Extreme sleep durations (\<5 or \<6 hr or \>10 hr) have been associated with cardiometabolic illness risk.
次要结局
- Physiological stress: circulating cortisol(Four nights, each morning a week apart, spanning one month)
- Physiological stress: electrocardiogram (ECG) heart rate (HR)(Four nights, each night a week apart, spanning one month)
- Physiological stress: respirometry respiration rate(Four nights, each night a week apart, spanning one month)
- Physiological stress: electrocardiogram (ECG) heart rate variability (HRV)(Four nights, each night a week apart, spanning one month)
- Physiological stress: inflammatory immune factors (cytokines and kynurenines)(Four mornings, each morning a week apart, spanning one month)
- Awakening response: Psychomotor Vigilance Task (PVT)(Four mornings, each morning a week apart, spanning one month)
- Sleep inertia Questionnaire - Acute (SIQ - Acute)(Four mornings, each morning a week apart, spanning one month)
- Subjective ratings of mood: Positive and Negative Affect Scale (PANAS)(Four nights, each night a week apart, spanning one month)
- Subjective ratings of mood: State Trait Anxiety Inventory (STAI)(Four nights, each night a week apart, spanning one month)
- Awakening response: cortisol(Four mornings, each morning a week apart, spanning one month)