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

NCT04721574 | Completed DMC

• 1 other identifier: 2016-05-005
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (5)

• total sleep duration in actigraphy

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

  4 weeks

• sleep onset latency in actigraphy

  the interval between time-to-bed and sleep onset

  4 weeks

• sleep efficiency in actigraphy

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

  4 weeks

• wake after sleep onset in actigraphy

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

  4 weeks

• number of awakenings in actigraphy

  number of awakenings

  4 weeks

Secondary Outcomes (7)

• the insomnia severity index

  4 weeks

• the Pittsburgh Sleep Quality Index

  4 weeks

• The Epworth Sleepiness Scale

  4 weeks

• the Fatigue Severity Scale

  4 weeks

• The Patient Health Questionnaire-9

  4 weeks

Study Arms (2)

Bright light therapy

ACTIVE COMPARATOR

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

Device: Philips EnergyUp Energy light HF3418/01

Sham Therapy

SHAM COMPARATOR

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

Device: Philips EnergyUp Energy light HF3418/01 with filter

Interventions

Philips EnergyUp Energy light HF3418/01 DEVICE

high brightness LED light box

Also known as: Bright light therapy

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

Also known as: Bright light therapy with filter

Sham Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha university hospital

Incheon, Jung-Gu, 22332, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34581703 DERIVED

MeSH Terms

Interventions

Ultraviolet Therapy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: double-blind, placebo-controlled

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)