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

Not Applicable

Completed

• Conditions: Stroke Sequelae

• 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

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-25

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.

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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
the Pittsburgh Sleep Quality Index	4 weeks	Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality

Trial Locations

Locations (1)

Inha university hospital; 🇰🇷 Incheon, Jung-Gu, Korea, Republic of