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
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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