The Feasibility and Preliminary Effects of Novel Light Therapy in Individuals with Neurological Disorders- Multiple Sclerosis

Edith Cowan University0 个研究点目标入组 58 人开始时间: 2021年6月21日最近更新: 2023年1月23日

适应症

试验速览

暂无简介。

•1) confirmed clinical diagnosis of multiple sclerosis using the revised McDonald criteria, and in the case of relapsing-remitting MS, clinically verified stable disease in the four weeks leading up to the study.
•2) a score of equal to or greater than 4 on the Fatigue Severity Scale and/or a score of equal to or greater than 5 on the Pittsburgh Sleep Quality Index (indicative of self-perceived poor sleep quality) and/or a score of equal to or greater than 10 on the Epworth Sleepiness Scale (indicative of daytime somnolence),
•3) between the ages of 18 and 65,
•4) the capacity to speak reasonable English, understand verbal and written instructions and be able to complete tests and questionnaires without significant assistance,
•5) be able to give informed consent to participate in the study in accordance with the ICH GCP guidelines before initiating any study related procedures.

•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) symptomatology of severe untreated depression (defined by a score of equal to or greater than 11 on the depression component of the DASS-21), and
•7) pre-existing chronic fatigue syndrome, narcolepsy or sleep apnoea

发起方