MedPath

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

Not Applicable
Completed
Conditions
Stroke Sequelae
Interventions
Device: Philips EnergyUp Energy light HF3418/01 with filter
Device: 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
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.
Read More
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)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham TherapyPhilips EnergyUp Energy light HF3418/01 with filterLight-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening.
Bright light therapyPhilips EnergyUp Energy light HF3418/01Daily 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
NameTimeMethod
wake after sleep onset in actigraphy4 weeks

sum \[in minutes\] of all awake epochs between sleep onset and sleep end

number of awakenings in actigraphy4 weeks

number of awakenings

total sleep duration in actigraphy4 weeks

the sum \[in minutes\] of all sleep epochs between sleep onset and sleep end

sleep efficiency in actigraphy4 weeks

(SE%, the percentage of time spent asleep while in bed

sleep onset latency in actigraphy4 weeks

the interval between time-to-bed and sleep onset

Secondary Outcome Measures
NameTimeMethod
The Epworth Sleepiness Scale4 weeks

Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness

the insomnia severity index4 weeks

Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia

The World Health Organization Quality of Life Scale Abbreviated Version4 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 Index4 weeks

Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality

the Fatigue Severity Scale4 weeks

Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue.

The Patient Health Questionnaire-94 weeks

depression, 0-27, higher scores indicate more severe of depression.

The generalized Anxiety Disorder-74 weeks

anxiety, 0-21, higher scores indicate more severe of anxiety

Trial Locations

Locations (1)

Inha university hospital

🇰🇷

Incheon, Jung-Gu, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath