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

Primary Purpose

Stroke Sequelae

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Philips EnergyUp Energy light HF3418/01
Philips EnergyUp Energy light HF3418/01 with filter
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Sequelae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Inha university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Bright light therapy

Sham Therapy

Arm Description

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

Light-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2021
Last Updated
January 21, 2021
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04721574
Brief Title
Bright Light Therapy on Post-stroke Insomniawith Post-stroke Insomnia
Official Title
The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright light therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham Therapy
Arm Type
Sham Comparator
Arm Description
Light-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening.
Intervention Type
Device
Intervention Name(s)
Philips EnergyUp Energy light HF3418/01
Other Intervention Name(s)
Bright light therapy
Intervention Description
high brightness LED light box
Intervention Type
Device
Intervention Name(s)
Philips EnergyUp Energy light HF3418/01 with filter
Other Intervention Name(s)
Bright light therapy with filter
Intervention Description
high brightness LED light box with filters that reduced lamp output to less than 50 lux
Primary Outcome Measure Information:
Title
total sleep duration in actigraphy
Description
the sum [in minutes] of all sleep epochs between sleep onset and sleep end
Time Frame
4 weeks
Title
sleep onset latency in actigraphy
Description
the interval between time-to-bed and sleep onset
Time Frame
4 weeks
Title
sleep efficiency in actigraphy
Description
(SE%, the percentage of time spent asleep while in bed
Time Frame
4 weeks
Title
wake after sleep onset in actigraphy
Description
sum [in minutes] of all awake epochs between sleep onset and sleep end
Time Frame
4 weeks
Title
number of awakenings in actigraphy
Description
number of awakenings
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
the insomnia severity index
Description
Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia
Time Frame
4 weeks
Title
the Pittsburgh Sleep Quality Index
Description
Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality
Time Frame
4 weeks
Title
The Epworth Sleepiness Scale
Description
Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness
Time Frame
4 weeks
Title
the Fatigue Severity Scale
Description
Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue.
Time Frame
4 weeks
Title
The Patient Health Questionnaire-9
Description
depression, 0-27, higher scores indicate more severe of depression.
Time Frame
4 weeks
Title
The generalized Anxiety Disorder-7
Description
anxiety, 0-21, higher scores indicate more severe of anxiety
Time Frame
4 weeks
Title
The World Health Organization Quality of Life Scale Abbreviated Version
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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)
Facility Information:
Facility Name
Inha university hospital
City
Incheon
State/Province
Jung-Gu
ZIP/Postal Code
22332
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34581703
Citation
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.
Results Reference
derived

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

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