Chilipad for Sleep and Symptoms of PTSD
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- PROMIS Sleep Related Impairment Short Form
研究概览
简要总结
The purpose of this study is to obtain pilot data in preparation for future research designed to formally evaluate the effectiveness of the Chilipad for patients with PTSD
详细描述
This is a prospective cohort, before-after trial. 20 subjects with PTSD or PTSD symptoms (per patient report) will use the Chilipad nightly for 5 weeks after completing a short battery of PROMIS questionnaires. During the 5-week study intervention, subjects will also wear an OURA ring on a finger. The OURA week measures sleep duration and quality. 5 weeks after study enrollment, patients will repeat the battery or PROMIS questionnaires and will return the Chilipad and OURA rings, both of which will be provided free of charge by the Chilipad and OURA manufacturers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who have seen the study PI (Remy Coeytaux, MD, PhD) for an integrative medicine consultation between September 1, 2018 and April 30, 2019 and who report having been diagnoses with PTSD or who believe they may have PTSD or PTSD-related symptoms are eligible to participate.
排除标准
- •No exclusion criteria
结局指标
主要结局
PROMIS Sleep Related Impairment Short Form
时间窗: 5-week after intervention
PROMIS sleep related impairment short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome.
次要结局
- OURA ring timing metric(Nightly for 5 weeks)
- PROMIS Anger Short form(5-week after intervention)
- OURA ring Efficiency metric(Nightly for 5 weeks)
- OURA ring REM metric(Nightly for 5 weeks)
- OURA ring latency metric(Nightly for 5 weeks)
- OURA ring lowest resting heart rate(Nightly for 5 weeks)
- PROMIS anxiety short form(5-week prior intervention)
- OURA ring total sleep metric(Nightly for 5 weeks)
- OURA ring DEEP sleep metric(Nightly for 5 weeks)
- OURA ring heart rate variability(Nightly for 5 weeks)
- OURA ring respiration rate(Nightly for 5 weeks)
- OURA ring sleep score metric(Nightly for 5 weeks)
- OURA ring resting heart rate(Nightly for 5 weeks)
- OURA ring readiness score(Nightly for 5 weeks)