ACTRN12621000917831尚未招募未知
The Feasibility and Effects of Novel Light Therapy in Individuals with Neurological Conditions- Stroke
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 58
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 o limit(—)
- 性别
- All
入选标准
- •1)Have experienced an ischaemic or haemorrhagic stroke at least three months prior to enrolling in the study
- •2)Have persistent self-reported fatigue: a score of greater than 4 on the Fatigue Severity Scale and/or a score of greater than or equal to 5 on the Pittsburgh Sleep Quality Index (indicative of self-perceived poor sleep quality) and/or a score of greater than or equal to 10 on the Epworth Sleepiness Scale (indicative of daytime somnolence)
- •3)18 years of age or older
- •4)Have a modified Rankin Score (mRS) of less than or equal to 4
- •5)Have the capacity to speak reasonable English, understand verbal and written instructions and be able to complete tests and questionnaires without significant assistance
- •6)Be able to give informed consent to participate in the study in accordance with the ICH GCP guidelines before initiating any study related procedures
排除标准
- •1)Untreated hallucinations or psychosis,
- •2)Current use of hypnosedative or illicit stimulant drugs,
- •3)Use of antidepressants, unless the participant has been receiving a stable dose for at least four weeks,
- •4)Visual abnormalities that may interfere with light therapy, including cataracts, narrow-angle glaucoma or blindness,
- •5)Transmeridian travel or night shift work in the six weeks leading up to the study (or the intention to travel or undertake night shift during the study),
- •6)Severe untreated depression (defined by a score of greater than or equal to 11 on the depression component of the DASS-21)
- •7)Pre-existing chronic fatigue syndrome, narcolepsy or sleep apnoea
研究者
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