Bright Light Therapy on Post-stroke Insomniawith Post-stroke Insomnia
NCT ID: NCT04721574
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2016-08-01
2018-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bright light therapy
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
Philips EnergyUp Energy light HF3418/01
high brightness LED light box
Sham Therapy
Light-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening.
Philips EnergyUp Energy light HF3418/01 with filter
high brightness LED light box with filters that reduced lamp output to less than 50 lux
Interventions
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Philips EnergyUp Energy light HF3418/01
high brightness LED light box
Philips EnergyUp Energy light HF3418/01 with filter
high brightness LED light box with filters that reduced lamp output to less than 50 lux
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Inha University Hospital
OTHER
Responsible Party
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Wonhyoung Kim
Professor
Locations
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Inha university hospital
Incheon, Jung-Gu, South Korea
Countries
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References
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Kim WH, Joa KL, Kim CB, Lee HS, Kang SG, Jung HY, Bae JN. The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients With Poststroke Insomnia. Psychosom Med. 2022 Jan 1;84(1):123-130. doi: 10.1097/PSY.0000000000001014.
Other Identifiers
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2016-05-005
Identifier Type: -
Identifier Source: org_study_id
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