Bright Light Therapy on Post-stroke Insomniawith Post-stroke Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients

Conditions
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Stroke Sequelae

Intervention / Treatment
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* Device: Philips EnergyUp Energy light HF3418/01
* Device: Philips EnergyUp Energy light HF3418/01 with filter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Mini Mental State Examination (MMSE) score of ≤10 recurrent stroke aphasia 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind, placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bright light therapy<br>Daily exposure to a high brightness LED light box for 30 minutes as soon as possible after awakening, preferably between 7 and 8 AM in the patient's hospital room The device emits 10,000 lux of cool-white fluorescent light at 50-75 cm from the screen to the cornea with an ultraviolet filter | Device: Philips EnergyUp Energy light HF3418/01<br>* high brightness LED light box<br>* Other names: Bright light therapy;|
| Sham Comparator: Sham Therapy<br>Light-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening. | Device: Philips EnergyUp Energy light HF3418/01 with filter<br>* high brightness LED light box with filters that reduced lamp output to less than 50 lux<br>* Other names: Bright light therapy with filter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleep duration in actigraphy | the sum [in minutes] of all sleep epochs between sleep onset and sleep end | 4 weeks | 
| sleep onset latency in actigraphy | the interval between time-to-bed and sleep onset | 4 weeks | 
| sleep efficiency in actigraphy | (SE%, the percentage of time spent asleep while in bed | 4 weeks | 
| wake after sleep onset in actigraphy | sum [in minutes] of all awake epochs between sleep onset and sleep end | 4 weeks | 
| number of awakenings in actigraphy | number of awakenings | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the insomnia severity index | Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia | 4 weeks | 
| the Pittsburgh Sleep Quality Index | Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality | 4 weeks | 
| The Epworth Sleepiness Scale | Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness | 4 weeks | 
| the Fatigue Severity Scale | Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue. | 4 weeks | 
| The Patient Health Questionnaire-9 | depression, 0-27, higher scores indicate more severe of depression. | 4 weeks | 
| The generalized Anxiety Disorder-7 | anxiety, 0-21, higher scores indicate more severe of anxiety | 4 weeks | 
| The World Health Organization Quality of Life Scale Abbreviated Version | overall quality of life through self-reporting, with four subscales in overall health: physical health, psychological health, social relationships, and environmental health. The higher sum in each subscale signified better quality of life. | 4 weeks |