Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Frequency of Daytime Naps
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury
- •Male or female, 18 to 85 years of age (to match limits of assessment instruments)
- •Able to provide written informed consent or have a legally authorized representative that can provide written informed consent
- •Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms
- •Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure)
- •Normal hearing or corrected to normal hearing
- •Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment
排除标准
- •History of epileptic or other seizure disorder
- •Cataract surgery in the past 12 months
- •Significant visual impairment affecting light reaching the retina/performance of the retina: cataracts, macular degeneration, diabetic retinopathy, congenital blindness, total blindness, glaucoma, or retinal detachment
- •Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's)
- •Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome
- •Neurological disorders other than those attributed to the primary diagnosis, including multiple sclerosis, Parkinson's disease, Huntington's disease, Alzheimer's disease or other dementias, amyotrophic lateral sclerosis)
- •Bipolar diagnosis
- •Females who are pregnant as determined from subject's medical records or who are breastfeeding
- •In active withdrawal from alcohol or street drugs
- •Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure
结局指标
主要结局
Frequency of Daytime Naps
时间窗: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Recording of number of naps during daytime via wrist-worn actigraph
Sleep Efficiency
时间窗: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph
Total Sleep Time
时间窗: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
24/7 recording of total amount of time asleep via wrist-worn actigraph
Sleep Fragmentation Index
时间窗: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Recording of restlessness during a sleep period via wrist-worn actigraph
次要结局
- Wits Pictorial Sleepiness Scale(Baseline and every 3 days plus at study completion, at least 10 days after consent)
- Karolinska Sleepiness Scale(Baseline and every 3 days plus at study completion, at least 10 days after consent)
- Fatigue Visual Analog Scale(Baseline and every 3 days plus at study completion, at least 10 days after consent)
研究者
Douglas L. Weeks
Director of Research
St. Luke's Rehabilitation Institute