Effect of Bright Light on Mood and Sleep in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Mood
研究概览
简要总结
The purpose of this clinical trial is to investigate whether light therapy is a suitable treatment option for depression and insomnia in Parkinson's disease.
详细描述
The quality of life of patients with Parkinson's disease and their caretakers is mainly influenced by so called non-motor symptoms. This includes neuropsychiatric consequences of the disease like depression and sleeping problems. The incidence of depressed mood in patients with Parkinson is approximately 50%, the incidence for sleeping problems is 90%. These symptoms are often overlooked and even if recognized, inadequately treated. The treatment of mood and sleep disturbances in Parkinson patients is hampered by adverse effects, incomplete responses to the usual treatments and the absence of specific treatment options for these symptoms in Parkinson's disease. On the basis of the hypothesis of disturbed functioning of the suprachiasmatic nucleus in Parkinson's disease it is expected that stimulation of this nucleus by bright light therapy will result in improved functioning on multiple different domains: mood, sleep, motor functions, quality of life and circadian rhythms. Because there are virtually no side effects and the possibility of home treatment, light therapy is expected to be highly appreciated by the patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease
- •depression
排除标准
- •psychosis
- •suicidality
- •retinopathy
- •previous light treatment
- •use of photosensitising medication
结局指标
主要结局
Mood
时间窗: T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0
using Hamilton Depression Rating Scale (HDRS - 17 items) and Geriatric Depression Scale-30 (GDS - 30 items) at baseline (T0), halfway therapy, six weeks (T1), end of therapy, three months (T2), at 1 month follow-up (T3), 3 months follow-up (T4) and 6 months follow-up (T5). * The direct treatment effect (= difference score between baseline and end of treatment), * The long-lasting treatment effect (= difference score between baseline and end of follow-up). * The dichotomous treatment response (\> 50 % decrease score at T2), in order to calculate the Numbers Needed to Treat (NNT).
次要结局
- Motor function(T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0)
- Sleep(T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0)
- Quality of Life of patient(T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0)
- Circadian rhythm(T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0)
- Quality of life of caregiver(T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0)
研究者
O.A. van den Heuvel
Principal Investigator
Amsterdam UMC, location VUmc