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

Stroke Sequelae Clinical Trial

Official title:

The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721574
• Other study ID #: 2016-05-005
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2021
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

Intervention

Device:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Inha university hospital	Incheon	Jung-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total sleep duration in actigraphy	the sum [in minutes] of all sleep epochs between sleep onset and sleep end	4 weeks
Primary	sleep onset latency in actigraphy	the interval between time-to-bed and sleep onset	4 weeks
Primary	sleep efficiency in actigraphy	(SE%, the percentage of time spent asleep while in bed	4 weeks
Primary	wake after sleep onset in actigraphy	sum [in minutes] of all awake epochs between sleep onset and sleep end	4 weeks
Primary	number of awakenings in actigraphy	number of awakenings	4 weeks
Secondary	the insomnia severity index	Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia	4 weeks
Secondary	the Pittsburgh Sleep Quality Index	Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality	4 weeks
Secondary	The Epworth Sleepiness Scale	Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness	4 weeks
Secondary	the Fatigue Severity Scale	Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue.	4 weeks
Secondary	The Patient Health Questionnaire-9	depression, 0-27, higher scores indicate more severe of depression.	4 weeks
Secondary	The generalized Anxiety Disorder-7	anxiety, 0-21, higher scores indicate more severe of anxiety	4 weeks
Secondary	The World Health Organization Quality of Life Scale Abbreviated Version	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.	4 weeks