Effects of Bright Light Treatment on Daytime Sleepiness and Nocturnal Sleep in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.
研究概览
简要总结
Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. The primary outcome measure will be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability.
Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.
详细描述
See above.
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
- •Diagnosis of idiopathic PD as defined by the United Kingdom Parkinson's Disease Society Brain Bank Criteria
- •Hoehn and Yahr stage of 2 to 4 in the "on" state
- •Excessive daytime sleepiness as defined by the Epworth Sleepiness Scale (ESS) score of greater than or equal to 12 points
- •Stable PD medication regimen for at least 4 weeks prior to study screening
- •Willing and able to give written informed consent
排除标准
- •Atypical parkinsonian syndromes
- •Significant sleep disordered breathing (defined as an apnea-hypopnea index >15 events/hr of sleep on screening PSG)
- •Significant periodic limb movement disorder (defined as a PLM arousal index>10 events/hr of sleep on screening PSG) and REM sleep behavior disorder (based on the presence of both clinical symptomatology as well as intermittent loss of REM atonia on screening PSG)
- •Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24
- •Presence of depression defined as the Beck Depression Inventory (BDI) score >14
- •Untreated hallucinations or psychosis (drug-induced or spontaneous)
- •Use of hypno-sedative drugs for sleep or stimulants during the daytime
- •Use of antidepressants unless the patient has been on a stable dose for at least three months
- •Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness
- •Travel through 2 time zones within 90 days prior to study screening
结局指标
主要结局
Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.
时间窗: baseline and 4 weeks
ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.
次要结局
未报告次要终点
研究者
Aleksandar Videnovic
Assistant Professor of Neurology
Northwestern University