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

Inha University Hospital

Status: Completed

Conditions: Stroke Sequelae

Treatments: Device: Philips EnergyUp Energy light HF3418/01 with filter; Device: Philips EnergyUp Energy light HF3418/01

Study type: Interventional

Funder types: Other

Identifiers

NCT04721574

2016-05-005

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Bright light therapy

Active Comparator group

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

Treatment:

Device: Philips EnergyUp Energy light HF3418/01

Sham Therapy

Sham Comparator group

Description:

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

Treatment:

Device: Philips EnergyUp Energy light HF3418/01 with filter