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

NCT ID: NCT04721574

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Sequelae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind, placebo-controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Philips EnergyUp Energy light HF3418/01

Intervention Type DEVICE

high brightness LED light box

Sham Therapy

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

Group Type SHAM_COMPARATOR

Philips EnergyUp Energy light HF3418/01 with filter

Intervention Type DEVICE

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

Interventions

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Philips EnergyUp Energy light HF3418/01

high brightness LED light box

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Bright light therapy Bright light therapy with filter

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inha University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wonhyoung Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inha university hospital

Incheon, Jung-Gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 34581703 (View on PubMed)

Other Identifiers

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2016-05-005

Identifier Type: -

Identifier Source: org_study_id

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