NCT04721574已完成不适用
The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- wake after sleep onset in actigraphy
研究概览
简要总结
The objective of this study was to determine the effectiveness of bright light therapy as a treatment for early, mild-to-moderate stroke patients with post-stroke insomnia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first occurrence of stroke for the patient
- •matched International Classification of Diseases (ICD)-10 codes (nontraumatic subarachnoid hemorrhage [I60], nontraumatic intracerebral hemorrhage [I61], other and unspecified nontraumatic intracranial hemorrhage [I62], or cerebral infarction [I63]) (World Health Organization, 1997)
- •mild-to-moderate stroke (the National Institutes of Health Stroke Scale ≤14)
- •age ≥18 years
- •satisfactory cognitive function
- •post-stroke insomnia.
排除标准
- •Mini Mental State Examination (MMSE) score of ≤10
- •recurrent stroke
- •transient ischemic attack
- •schizophrenia, bipolar disorder, mood disorder, previous insomnia disorder, or dementia before stroke
- •taking sleeping pills or antidepressants for 5 or more days within a 6-month timespan before the onset of stroke
- •post-stroke delirium
- •a National Institutes of Health Stroke Scale score ≥ 14
- •previous eye disease or post-stroke eye disease
- •severe auditory impairment
- •the use of psychotropic medications (hypnotics, benzodiazepine, benzodiazepine agonists, antidepressants [mirtazapine or trazodone] or antipsychotics)
结局指标
主要结局
wake after sleep onset in actigraphy
时间窗: 4 weeks
sum \[in minutes\] of all awake epochs between sleep onset and sleep end
number of awakenings in actigraphy
时间窗: 4 weeks
number of awakenings
total sleep duration in actigraphy
时间窗: 4 weeks
the sum \[in minutes\] of all sleep epochs between sleep onset and sleep end
sleep efficiency in actigraphy
时间窗: 4 weeks
(SE%, the percentage of time spent asleep while in bed
sleep onset latency in actigraphy
时间窗: 4 weeks
the interval between time-to-bed and sleep onset
次要结局
- The Epworth Sleepiness Scale(4 weeks)
- the insomnia severity index(4 weeks)
- The World Health Organization Quality of Life Scale Abbreviated Version(4 weeks)
- the Pittsburgh Sleep Quality Index(4 weeks)
- the Fatigue Severity Scale(4 weeks)
- The Patient Health Questionnaire-9(4 weeks)
- The generalized Anxiety Disorder-7(4 weeks)
研究者
Wonhyoung Kim
Professor
Inha University Hospital
研究点 (2)
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