Stroke SequelaeNCT04721574
Bright Light Therapy on Post-stroke Insomniawith Post-stroke Insomnia
A study testing Philips EnergyUp Energy light HF3418/01 and Philips EnergyUp Energy light HF3418/01 with filter in people with Stroke Sequelae, run by Inha University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Philips EnergyUp Energy light HF3418/01 and Philips EnergyUp Energy light HF3418/01 with filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2016to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients
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
- Being tested
- Philips EnergyUp Energy light HF3418/01, Philips EnergyUp Energy light HF3418/01 with filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips EnergyUp Energy light HF3418/01Device
Also called Bright light therapy
high brightness LED light box
Philips EnergyUp Energy light HF3418/01 with filterDevice
Also called Bright light therapy with filter
high brightness LED light box with filters that reduced lamp output to less than 50 lux
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Philips EnergyUp Energy light HF3418/01 with filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
total sleep duration in actigraphy
the sum [in minutes] of all sleep epochs between sleep onset and sleep end
Measured: 4 weeks
sleep onset latency in actigraphy
the interval between time-to-bed and sleep onset
Measured: 4 weeks
sleep efficiency in actigraphy
(SE%, the percentage of time spent asleep while in bed
Measured: 4 weeks
wake after sleep onset in actigraphy
sum [in minutes] of all awake epochs between sleep onset and sleep end
Measured: 4 weeks
number of awakenings in actigraphy
number of awakenings
Measured: 4 weeks
Secondary outcomes (7)
the insomnia severity index
Subjective sleep parameters, 0-28, higher scores indicate more acute symptoms of insomnia
Measured: 4 weeks
the Pittsburgh Sleep Quality Index
Subjective sleep parameters, 0-21, higher scores indicate more poor sleep quality
Measured: 4 weeks
The Epworth Sleepiness Scale
Subjective sleep parameters, 0-24, 0-28, higher scores indicate more daytime sleepiness
Measured: 4 weeks
the Fatigue Severity Scale
Subjective sleep parameters, 0-36, 0-28, higher scores indicate greater fatigue.
Measured: 4 weeks
The Patient Health Questionnaire-9
depression, 0-27, higher scores indicate more severe of depression.
Measured: 4 weeks
The generalized Anxiety Disorder-7
anxiety, 0-21, higher scores indicate more severe of anxiety
Measured: 4 weeks
The World Health Organization Quality of Life Scale Abbreviated Version
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Aug 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonhyoung Kim, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721574
- Sponsor's protocol ID
- 2016-05-005
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34581703
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients
- ClinicalTrials.gov ID
- NCT04721574
- Acronym / sponsor ID
- 2016-05-005
- Conditions
- Stroke Sequelae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Bright light therapy | Active comparator | Device: Philips EnergyUp Energy light HF3418/01Daily 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 |
| Sham Therapy | Sham comparator | Device: Philips EnergyUp Energy light HF3418/01 with filterLight-therapy with filters that reduced lamp output to less than 50 lux. for 30 minutes as soon as possible after awakening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips EnergyUp Energy light HF3418/01Also: Bright light therapyhigh brightness LED light box | Device | Bright light therapy |
| Philips EnergyUp Energy light HF3418/01 with filterAlso: Bright light therapy with filterhigh brightness LED light box with filters that reduced lamp output to less than 50 lux | Device | Sham Therapy |
Primary outcome
total sleep duration in actigraphy
Time frame: 4 weeks
the sum [in minutes] of all sleep epochs between sleep onset and sleep end
sleep onset latency in actigraphy
Time frame: 4 weeks
the interval between time-to-bed and sleep onset
sleep efficiency in actigraphy
Time frame: 4 weeks
(SE%, the percentage of time spent asleep while in bed
wake after sleep onset in actigraphy
Time frame: 4 weeks
sum [in minutes] of all awake epochs between sleep onset and sleep end
number of awakenings in actigraphy
Time frame: 4 weeks
number of awakenings
7 secondary outcomes
the insomnia severity index
Time frame: 4 weeks
the Pittsburgh Sleep Quality Index
Time frame: 4 weeks
The Epworth Sleepiness Scale
Time frame: 4 weeks
the Fatigue Severity Scale
Time frame: 4 weeks
The Patient Health Questionnaire-9
Time frame: 4 weeks
The generalized Anxiety Disorder-7
Time frame: 4 weeks
The World Health Organization Quality of Life Scale Abbreviated Version
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 34581703Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips EnergyUp Energy light HF3418/01 and Philips EnergyUp Energy light HF3418/01 with filter in people with Stroke Sequelae, run by Inha University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total sleep duration in actigraphy (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.