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临床试验/ACTRN12621000917831
ACTRN12621000917831尚未招募未知

The Feasibility and Effects of Novel Light Therapy in Individuals with Neurological Conditions- Stroke

Edith Cowan University0 个研究点目标入组 58 人开始时间: 2021年7月15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
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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