Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 6
- 主要终点
- Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%.
研究概览
简要总结
Post-Traumatic Stress Disorder (PTSD) is a public health problem due to both its chronic nature and the low response rate to conventional therapies.
Sleep disorders are the first cause of complaint in patients with PTSD due to night awakenings, difficulty to fall asleep and nightmares.
According to a part of the scientific community, replicative traumatic nightmares represent PTSD's basis mechanism. Traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. Traumatic nightmares may thus be a sign of PTSD seriousness and chronicity, although their physiological basis remain poorly known.
In the military population, which is highly exposed to psychological traumatism, PTSD prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Military or former military
- •Age between 18 and 65 years old
- •PTSD group : with a PTSD diagnosis
- •Control group : without any sleep, psychiatric or neurologic pathology
排除标准
- •Diagnosis of progressive psychiatric pathology prior to the traumatic event responsible for PTSD
- •Sleep pathology prior to the traumatic event responsible for PTSD
- •Neurological pathology or severe head injury within the last 3 years
结局指标
主要结局
Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%.
时间窗: 1 month after enrollment
The sleep efficiency index (SEI) is defined by the ratio TST/TIB with TST being Total Sleep Time and TIB being Time In Bed. TST and TIB will be assessed objectively, at home, using a connected headband (DREEM®, Rythm Paris). A Sleep Efficiency Index (SEI) \< 80% is considered to be a poor quality, low-efficiency night.
次要结局
未报告次要终点