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临床试验/ACTRN12619000950167
ACTRN12619000950167尚未招募未知

Evaluation of a portable light device for phase advancing the circadian rhythms of those suffering from sleep-onset insomnia

Flinders University0 个研究点目标入组 24 人开始时间: 2019年7月5日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 64 Years(—)
性别
All

入选标准

  • Symptoms that meet the criteria for a diagnosis of insomnia, according to the ICSD-3. Specifically;
  • 1. Sleep diary data which indicates difficulties initiating sleep (>30-minute latency to sleep) at least three times in the one-week screening assessment period.
  • 2. Sleep and daytime functioning questionnaire scores which indicate insomnia:
  • oInsomnia Severity Index >10

排除标准

  • a)Taking any medication that would affect sleep/melatonin production
  • b)Had recent eye surgery or a chronic eye condition,
  • c)Difficulties with the English language that would prevent informed consent,
  • d)Receiving other forms of sleep treatment,
  • e)Diagnosis of sleep disorder other than insomnia,
  • f)Were habitual high consumers of caffeine (greater than or equal to 250 mg daily) and/or alcohol (greater than or equal to 14 standard drinks per week),
  • g)Indicated a history of substance abuse in the last 12 months,
  • h)Worked a night shift in the previous 2 months (night shift was defined as a work schedule including at least 6 h of work between 10:00 p.m. And 8:00 a.m.),
  • i)Undertook trans-meridian travel (two time zones) in the last 2 months,
  • j)Pregnant or lactating, or
  • k)Clinically diagnosed depression.

研究者

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