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临床试验/NCT01042587
NCT01042587已完成不适用

Effect of Bright Light Treatment On Elders In A Long Term Care Environment

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
assessment of cognitive functioning using MicroCog

研究概览

简要总结

The investigators hypothesize that significant exposure to artificial morning bright light (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as compared to sham bright red light (placebo) will:

  1. improve sleep quality
  2. improve cognitive scores
  3. improve depression scores
  4. improve quality of life scores.

详细描述

Bright light therapy has been shown to improve depression and insomnia in multiple studies. These are common conditions among elders, particularly those residing in long term care environments. Bright light therapy has been inadequately studied in the geriatric population. We will show that a groups of twenty elders can simultaneous be exposed to bright light and that it will result in improvements in multiple realms of behavior and quality of life. Elders will be tested with a number of neuropsychological test batteries prior to exposure to bright light and again at the end of a four week exposure. Some subjects will have daytime and night time activity levels monitored with actigraphy. Cortisol and melatonin levels will be obtained prior to and at the end of the exposure period.

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, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •residents in Masonic Villages, Elizabethtown, PA long term care
  • •ability to give informed consent and complete the neuropsychological tests

排除标准

  • •blindness
  • •severe illness expected to preclude the ability to complete treatment
  • •moderate to severe dementia that precludes the ability to complete testing
  • •light sensitivity making treatment to light therapy uncomfortable

研究组 & 干预措施

bright light

Active Comparator

Bright light has been shown to entrain circadian rhythm so our treatment arm will use thirty minutes of early morning exposure to bright blue light for a four week period.

干预措施: exposure to bright light (Other)

red light

Sham Comparator

Low level red light is a weak entrainment stimulus of circadian rhythm. Elders in the control group will be exposed to low level red light as a placebo for thirty minutes daily for four weeks.

干预措施: low luminosity red light (Other)

结局指标

主要结局

assessment of cognitive functioning using MicroCog

时间窗: once prior to intervention, once near the end of intervention, once four weeks after intervention

Assessment of mood using the Geriatric Depression Scale

时间窗: once prior to intervention, once near the end of intervention, once four weeks after intervention

assessment of quality of life using the SF-36

时间窗: once prior to intervention, once near the end of intervention, once four weeks after intervention

assessment of sleep quality using the Pittsburgh Sleep Quality Index

时间窗: once prior to intervention, once near the end of intervention, once four weeks after intervention

assessment of mood using the Profile of Moods Survey

时间窗: weekly throughout the duration of the study

assessment of sleep quality using the Epworth Sleepiness Scale

时间窗: weekly throughout the duration of the study

day and nightime activity level (5 subjects per group only) using Actigraphy

时间窗: two weeks prior to light exposure and the second two weeks during light exposure (continuous measurements)

次要结局

  • salivary melatonin levels(once prior and near the end of light exposure period)
  • salivary cortisol levels(once prior and near the end of light exposure period)

研究者

申办方类型
Other

研究点 (1)

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