NCT04721574
Completed
Not Applicable
The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients
ConditionsStroke Sequelae
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke Sequelae
- Sponsor
- Inha University Hospital
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- wake after sleep onset in actigraphy
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Wonhyoung Kim
Professor
Inha University Hospital
Eligibility Criteria
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
- •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)
Outcomes
Primary Outcomes
wake after sleep onset in actigraphy
Time Frame: 4 weeks
sum \[in minutes\] of all awake epochs between sleep onset and sleep end
number of awakenings in actigraphy
Time Frame: 4 weeks
number of awakenings
total sleep duration in actigraphy
Time Frame: 4 weeks
the sum \[in minutes\] of all sleep epochs between sleep onset and sleep end
sleep efficiency in actigraphy
Time Frame: 4 weeks
(SE%, the percentage of time spent asleep while in bed
sleep onset latency in actigraphy
Time Frame: 4 weeks
the interval between time-to-bed and sleep onset
Secondary Outcomes
- The Epworth Sleepiness Scale(4 weeks)
- the insomnia severity index(4 weeks)
- The World Health Organization Quality of Life Scale Abbreviated Version(4 weeks)
- the Pittsburgh Sleep Quality Index(4 weeks)
- the Fatigue Severity Scale(4 weeks)
- The Patient Health Questionnaire-9(4 weeks)
- The generalized Anxiety Disorder-7(4 weeks)
Study Sites (1)
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