Stroke Sequelae
Conditions
Brief summary
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.
Interventions
DEVICEPhilips EnergyUp Energy light HF3418/01
high brightness LED light box
DEVICEPhilips EnergyUp Energy light HF3418/01 with filter
high brightness LED light box with filters that reduced lamp output to less than 50 lux
Sponsors
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total sleep duration in actigraphy | 4 weeks | the sum \[in minutes\] of all sleep epochs between sleep onset and sleep end |
| sleep onset latency in actigraphy | 4 weeks | the interval between time-to-bed and sleep onset |
| sleep efficiency in actigraphy | 4 weeks | (SE%, the percentage of time spent asleep while in bed |
| wake after sleep onset in actigraphy | 4 weeks | sum \[in minutes\] of all awake epochs between sleep onset and sleep end |
| number of awakenings in actigraphy | 4 weeks | number of awakenings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The generalized Anxiety Disorder-7 | 4 weeks | anxiety, 0-21, higher scores indicate more severe of anxiety |
| the insomnia severity index | 4 weeks | Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia |
| The World Health Organization Quality of Life Scale Abbreviated Version | 4 weeks | 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. |
| the Pittsburgh Sleep Quality Index | 4 weeks | Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality |
| The Epworth Sleepiness Scale | 4 weeks | Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness |
| the Fatigue Severity Scale | 4 weeks | Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue. |
| The Patient Health Questionnaire-9 | 4 weeks | depression, 0-27, higher scores indicate more severe of depression. |
Countries
South Korea
Outcome results
None listed