Bright Light Therapy on Post-stroke Insomniawith Post-stroke Insomnia
- Conditions
- Stroke Sequelae
- Interventions
- Device: Philips EnergyUp Energy light HF3418/01 with filterDevice: Philips EnergyUp Energy light HF3418/01
- Registration Number
- NCT04721574
- Lead Sponsor
- Inha University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Therapy Philips EnergyUp Energy light HF3418/01 with filter Light-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening. Bright light therapy Philips EnergyUp Energy light HF3418/01 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
- Primary Outcome Measures
Name Time Method 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
total sleep duration in actigraphy 4 weeks the sum \[in minutes\] of all sleep epochs between sleep onset and sleep end
sleep efficiency in actigraphy 4 weeks (SE%, the percentage of time spent asleep while in bed
sleep onset latency in actigraphy 4 weeks the interval between time-to-bed and sleep onset
- Secondary Outcome Measures
Name Time Method The Epworth Sleepiness Scale 4 weeks Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness
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 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.
The generalized Anxiety Disorder-7 4 weeks anxiety, 0-21, higher scores indicate more severe of anxiety
Trial Locations
- Locations (1)
Inha university hospital
🇰🇷Incheon, Jung-Gu, Korea, Republic of