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Completed

NCT Number: NCT04721574

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

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.

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Key information

Conditions

Stroke Sequelae

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inha university hospital

Incheon, Jung-Gu, 22332, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Philips EnergyUp Energy light HF3418/01

Device

high brightness LED light box

Other names: Bright light therapy

Philips EnergyUp Energy light HF3418/01 with filter

Device

high brightness LED light box with filters that reduced lamp output to less than 50 lux

Other names: Bright light therapy with filter

Primary outcomes

  1. total sleep duration in actigraphy

    Time frame: 4 weeks

    the sum [in minutes] of all sleep epochs between sleep onset and sleep end

  2. sleep onset latency in actigraphy

    Time frame: 4 weeks

    the interval between time-to-bed and sleep onset

  3. sleep efficiency in actigraphy

    Time frame: 4 weeks

    (SE%, the percentage of time spent asleep while in bed

  4. wake after sleep onset in actigraphy

    Time frame: 4 weeks

    sum [in minutes] of all awake epochs between sleep onset and sleep end

  5. number of awakenings in actigraphy

    Time frame: 4 weeks

    number of awakenings

Secondary outcomes

  1. the insomnia severity index

    Time frame: 4 weeks

    Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia

  2. the Pittsburgh Sleep Quality Index

    Time frame: 4 weeks

    Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality

  3. The Epworth Sleepiness Scale

    Time frame: 4 weeks

    Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness

  4. the Fatigue Severity Scale

    Time frame: 4 weeks

    Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue.

  5. The Patient Health Questionnaire-9

    Time frame: 4 weeks

    depression, 0-27, higher scores indicate more severe of depression.

  6. The generalized Anxiety Disorder-7

    Time frame: 4 weeks

    anxiety, 0-21, higher scores indicate more severe of anxiety

  7. The World Health Organization Quality of Life Scale Abbreviated Version

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 22, 2021
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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