Effects of Continuous Positive Airway Pressure Therapy for Obstructive Sleep Apnea on PTSD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms measured by the PTSD checklist (PCL-S).
研究概览
简要总结
The purpose of this study is to evaluate the effects of treating Obstructive Sleep Apnea (OSA) with continuous positive airway pressure (CPAP) therapy on symptoms of post traumatic stress disorder (PTSD). The study hypotheses are that CPAP use will improve PTSD symptoms overall and that CPAP use will improve sleep quality and duration, nocturnal symptoms related to PTSD, mood, daytime sleepiness, sleep-related quality of life, and general health perception.
详细描述
Post traumatic stress disorder (PTSD) is associated with increased healthcare utilization, decreased functional status, and overall poor health. Sleep disturbances in PTSD are common, including nightmares, dream enactment, and poor sleep quality. Obstructive sleep apnea (OSA) is also highly prevalent in the veteran population and may exacerbate PTSD symptoms by triggering arousals from sleep that promote recollection of dreams, enactment of dreams, and disrupt sleep continuity. Improvements in sleep quality and PTSD symptoms have been reported when OSA is treated with continuous positive airway pressure (CPAP) therapy. However, formal assessment using validated questionnaires and documentation of CPAP compliance to correlate with these tools has not yet been performed. This study will recruit veterans with PTSD who have been newly diagnosed with OSA and who are willing to try CPAP therapy. Baseline assessments of PTSD symptoms, daytime sleepiness, sleep-related quality of life, sleep quality, general health perception, and mood will be performed before initiation of treatment and after 3 and 6 months of therapy.
This study will have the following specific aims:
Aim 1: To evaluate the effect of CPAP use on PTSD symptoms.
Hypothesis: After 6 months of treatment, CPAP use will improve PTSD symptoms as assessed by the PTSD checklist (PCL-S).
Aim 2: To evaluate the effect of CPAP use on 1)sleep quality and duration, 2)nocturnal symptoms of nightmares, movement disorders, dream enactment, and insomnia, 3)mood, 4)daytime sleepiness, 5)sleep-related quality of life, and 6) general health perception.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The intent is to recruit a study population that is as representative as possible of the veteran PTSD population. Thus, entry criteria are as inclusive as possible:
- •age >18 year
- •confirmed diagnosis of PTSD (PCL checklist minimum score of 45)
- •confirmed diagnosis of sleep apnea (apnea hypopnea index >5/h)
- •newly starting CPAP (not previously treated)
排除标准
- •fatal co-morbidity with life expectancy of less than 6 months,
- •residing in a geographically remote area that would make follow up at 3 and 6 months difficult.
结局指标
主要结局
Change in PTSD symptoms measured by the PTSD checklist (PCL-S).
时间窗: Baseline, 3 months, 6 months
A change of -10 points on the PCL-S has been previously determined to be clinically significant.
次要结局
- Daytime Sleepiness measured by the Epworth Sleepiness Scale (ESS)(Baseline, 3 months, 6 months)
- Sleep Related Quality of life with be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ-10).(Baseline, 3 months, 6 months)
- Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).(Baseline, 3 months, 6 months)
- General health related quality of life.(Baseline, 3 months, 6 months)
- Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).(Baseline, 3 months, 6 months)