Randomized Placebo- and Active-controlled Trial for Assessing the Efficacy of Bright Light Therapy for Sleep and Mood Symptoms in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change of daytime sleepiness
研究概览
简要总结
This is a randomized placebo- and active-controlled trial for assessing the efficacy of bright light therapy for sleep and mood symptoms in patients with Parkinson's disease
详细描述
The primary aim of this study is to compare the efficacy of timed-BLT (BLT group) in reducing excessive daytime sleepiness in patients with Parkinson's disease, when compared to a timed-inactivated negative ion generator (active-control group).
The secondary aims of the study are to examine the effect of timed-BLT on other non-motor symptoms, including depression, fatigue; and the quality of life.
Additional analyses will be carried out to examine the efficacy of the timed-placebo as compared to the random-time placebo (placebo group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The subjects will be explained that the study aims to test the efficacy of the different modalities of non-pharmacological treatments for depression including bright light therapy and the negative ion generator, without mentioning which one is the placebo. An independent outcome assessor will be blinded to the treatment allocation throughout the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease diagnosed by neurologist according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria
- •Capable to give informed consent
- •Maintained on stable dose of medications for Parkinson's disease/psychotropic drugs for at least four weeks prior to entry of the study
- •Score 14 or more on the Epworth Sleepiness Scale
排除标准
- •A current or past history of manic or hypomanic episode, schizophrenia, mental retardation, or substance use disorder. (Subjects with depression or anxiety disorders will not be excluded)
- •Unstable medical or psychiatric condition
- •Presence of substantial suicidal risk as judged by the clinician and/or screening instruments
- •Presence of active psychotic symptoms that might impair the ability to consent or validity of the interview
- •Cognitive impairment with score of 19 or below by the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
- •Contraindication to bright light therapy: history of light induced migraine. Epilepsy, current use of photosensitizing medications, presence of eye disease, e.g. retinal disease, severe cataract, glaucoma and blindness
- •Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview
- •Regular shift worker or trans-meridian flight in the past three months
- •Enrolment in another clinical trial of an investigational medicinal product or device
- •Subjects who are on exogenous melatonin
- •Patients with deep brain stimulation (DBS) implant
- •Patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome
结局指标
主要结局
Change of daytime sleepiness
时间窗: at the end of 6-week treatment
Change in the score of Epworth Sleepiness Scale (ESS), ESS score ranges from 0-24, higher score indicates greater sleepiness
次要结局
- Change of depressive symptoms(at the end of 6-week treatment)
- Change in quality of life(at the end of 6-week treatment)
- Change in fatigue symptoms(at the end of 6-week treatment)
研究者
Joey WY Chan
Clinical Associate Professor
Chinese University of Hong Kong