跳至主要内容
临床试验/NCT04236661
NCT04236661撤回不适用

Reports on Sleep Quality and Thermoregulation Among Veterans

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家开始时间: 2020年7月最近更新:
适应症

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

To assess and compare the quality of sleep self- reported by veterans with sleep disorders before and after use of the Chilipad cooling mattress pad

详细描述

A non-randomized convenience sampling study of N=20 adult male or female veterans (> 18 years of age) with self-reporting sleep disturbance and will utilize a Chilipad cooling mattress for the 5-week study period

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

入选标准

  • Adult male and female veteran patients (> 18 years of age)
  • Self-report of sleep disturbance, defined as "sleep of poor quality, timing, efficiency, or duration"

排除标准

  • Non-adult patients < 18 years of age.
  • Patients with chart documentation or self-report of illegal drug use, impaired orientation and cognition or currently incarcerated.
  • Initiated CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
  • Changed dose of a CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
  • Initiated antidepressants in the last 3 months.
  • Changed of an antidepressant in the last 3 months.
  • Patients who describe their health as fair or poor.

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 with 8-item 5-point Likert rating scale survey reflecting DSM-5 for sleep disturbance. The raw score on 8 items is determined, summed for a raw score, then a T-score table is utilized to compare with the subject's individual score. The result, rounded to the nearest whole number determines the score. The survey T-scores are interpreted as: \< 55 = none to slight; 55.0 - 59.9 = mild; 60.0 - 69.9 = moderate; and \> 70 = severe

次要结局

  • OURA ring Efficiency metric(Nightly for 5 weeks)
  • OURA ring respiration rate(Nightly for 5 weeks)
  • OURA ring total sleep metric(Nightly for 5 weeks)
  • OURA ring latency metric(Nightly for 5 weeks)
  • OURA ring timing metric(Nightly for 5 weeks)
  • OURA ring sleep score metric(Nightly for 5 weeks)
  • OURA ring resting heart rate(Nightly for 5 weeks)
  • OURA ring REM metric(Nightly for 5 weeks)
  • OURA ring DEEP sleep metric(Nightly for 5 weeks)
  • OURA ring Skin temperature(Nightly for 5 weeks)
  • OURA ring readiness score(Nightly for 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验