Clinical trial NCT04721574: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, placebo-controlled
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: total sleep duration in actigraphy
timeFrame: 4 weeks
measure: sleep onset latency in actigraphy
timeFrame: 4 weeks
measure: sleep efficiency in actigraphy
timeFrame: 4 weeks
measure: wake after sleep onset in actigraphy
timeFrame: 4 weeks
measure: number of awakenings in actigraphy
timeFrame: 4 weeks
Secondary outcomes:
measure: the insomnia severity index
timeFrame: 4 weeks
measure: the Pittsburgh Sleep Quality Index
timeFrame: 4 weeks
measure: The Epworth Sleepiness Scale
timeFrame: 4 weeks
measure: the Fatigue Severity Scale
timeFrame: 4 weeks
measure: The Patient Health Questionnaire-9
timeFrame: 4 weeks
measure: The generalized Anxiety Disorder-7
timeFrame: 4 weeks
measure: The World Health Organization Quality of Life Scale Abbreviated Version
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha university hospital
state: Jung-Gu
Study officials:
References:
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.