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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke Sequelae
• Intervention / Treatment: Device: Philips EnergyUp Energy light HF3418/01; Device: Philips EnergyUp Energy light HF3418/01 with filter

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jung-Gu
    • Incheon, Jung-Gu, Korea, Republic of, 22332
      • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bright light therapy; 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	Device: Philips EnergyUp Energy light HF3418/01; high brightness LED light box; Other Names: Bright light therapy
Sham Comparator: Sham Therapy; Light-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening.	Device: Philips EnergyUp Energy light HF3418/01 with filter; high brightness LED light box with filters that reduced lamp output to less than 50 lux; Other Names: Bright light therapy with filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total sleep duration in actigraphy	the sum [in minutes] of all sleep epochs between sleep onset and sleep end	4 weeks
sleep onset latency in actigraphy	the interval between time-to-bed and sleep onset	4 weeks
sleep efficiency in actigraphy	(SE%, the percentage of time spent asleep while in bed	4 weeks
wake after sleep onset in actigraphy	sum [in minutes] of all awake epochs between sleep onset and sleep end	4 weeks
number of awakenings in actigraphy	number of awakenings	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the insomnia severity index	Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia	4 weeks
the Pittsburgh Sleep Quality Index	Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality	4 weeks
The Epworth Sleepiness Scale	Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness	4 weeks
the Fatigue Severity Scale	Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue.	4 weeks
The Patient Health Questionnaire-9	depression, 0-27, higher scores indicate more severe of depression.	4 weeks
The generalized Anxiety Disorder-7	anxiety, 0-21, higher scores indicate more severe of anxiety	4 weeks
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

Collaborators and Investigators

• Sponsor: Inha University Hospital

Publications and helpful links

General Publications

• Kim WH, Joa KL, Kim CB, Lee HS, Kang SG, Jung HY, Bae JN. The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients With Poststroke Insomnia. Psychosom Med. 2022 Jan 1;84(1):123-130. doi: 10.1097/PSY.0000000000001014.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016-05-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No