Light Therapy in Parkinson's Disease: a Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes from baseline in total sleep time(TST) by polysomnography (PSG) at the end of each intervention period
研究概览
简要总结
The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease.
详细描述
As the most important biologic rhythm timer, exogenous light supplement has certain benefits for the improvement of sleep quality and dementia. At present, it is gradually used in sleep and neuropsychiatric diseases. In an open study, 120 patients with PD received 4000 to 6000 lux of light, for 60 minutes before habitual bedtime. The patients were followed up for several months to 8 years, and it found the patients who persisted in the treatment improved their mood, anxiety and motor function. Clinical studies have confirmed the safety and effectiveness of light in improving insomnia and daytime sleepiness of PD patients. It was found that strong light can significantly improve the patients' motor and non-motor symptoms. However, these findings have not been reported in Chinese PD patients. The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease and explore the possible mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the criteria of PD diagnosis of the MDS, PD patients were selected as the research object. The clinical symptoms of PD patients were consistent with Hoehn and Yahr stages 2-
- •All PD patients have maintained stable drug treatment for at least one month, signed clinical informed consent and agreed not to adjust drugs throughout the light test and follow-up period.
排除标准
- •Using hypnotic or stimulating drugs.
- •Using antidepressants, except stable drugs maintained for more than three months;
- •Visual impairment, such as cataract, glaucoma, blindness, etc;
- •Cognitive impairment (MMSE < 24);
- •There are uncontrollable hallucinations and mental diseases;
- •There are sleep phase delay / advance syndrome, shift work, jet lag, etc
结局指标
主要结局
Changes from baseline in total sleep time(TST) by polysomnography (PSG) at the end of each intervention period
时间窗: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Total sleep time is the sum of sleep time in each period. This outcome reflects change of patients' sleep quality.
Changes from baseline in sleep efficient by polysomnography (PSG) at the end of each intervention period
时间窗: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Sleep efficiency is the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed. This outcome reflects change of patients' sleep quality.
Change from baseline in REM sleep without atonia by (RWA) polysomnography (PSG) at the end of each intervention period
时间窗: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
REM sleep without atonia (RWA) is the PSG finding of persistent muscle tone during REM sleep, resulting in paroxysmal phasic or tonic EMG activity. Together with dream-enacting behavior (DEB), RSWA is a necessary diagnostic criterion of REM sleep behavior disorder (RBD). This outcome reflects change of RBD severity.
Change from baseline in sleep onset latency polysomnography (PSG) at the end of each intervention period
时间窗: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Sleep latency is the amount of time it takes patients to go from being fully awake to sleeping. Patients' sleep latency and how quickly they reach rapid eye movement (REM) sleep can be indicators of the amount and quality of sleep they are getting.
Change from baseline in Periodic Limb Movement during Sleep(PLMS) by polysomnography (PSG) at the end of each intervention period
时间窗: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Periodic limb movement during sleep (PLMS) is is described as a stereotypical involuntary movement during sleep. In particular, presenting more than 15 periodic limb movements per hour is related to daytime sleepiness due to low sleep quality. This outcome reflects change of patients' sleep quality.
Changes from baseline in duration and percentage of each sleep stage by polysomnography (PSG) at the end of each intervention period
时间窗: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Changes in the length and percentage of N1, N2, N3 and REM sleep,which reflect changes in sleep structure.
Changes from baseline in slow wave activity(SWA) and slow wave energy(SWE) by polysomnography (PSG) at the end of each intervention period
时间窗: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
SWA and SWE are indicators of sleep depth and homeostasis in PSG.
次要结局
- Changes from baseline in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes form baseline in Hoehn-Yahr scale at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes form baseline in PDSS-2 score scale at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes form baseline in Pittsburgh sleep quality index (PSQI) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in REM sleep behavior disorder questionnaire-Hong Kong (RBDQ-HK) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in Epworth sleepiness scale (ESS) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in Morningness-Eveningness Questionnaire (MEQ) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in Hamilton Anxiety Scale(HAMA) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes in Montreal Cognitive Assessment (MoCA) score at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in Non-Motor Symptoms Questionnaire at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in Parkinson's Disease Questionnaire (PDQ-39) at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in Fatigue Severity Scale (FSS) at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in electroencephalogram(EEG) at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in the rhythmic level of melatonin in serum and saliva at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in the rhythmic level of cortisol in serum and saliva at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
- Changes from baseline in functional magnetic resonance(fMRI) at the end of each intervention period(visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week))
研究者
Chun-Feng Liu
Professor
Second Affiliated Hospital of Soochow University