StrokeNCT02186392
The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit
A study testing Circadian Light luminaries in people with Stroke and Sleep Apnea Syndromes, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the impact of exposure to ergonomic circadian light on physiological and mental parameters in stroke patients admitted for rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Sleep Apnea Syndromes, Depression
- What is being tested?
- Circadian Light luminaries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to 15 Aug 2016
- 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
- Patients evaluated as candidates to the rehabilitation units from May 1th 2014 to May 1th 2015.
Who cannot join
- Glasgow Coma Scale (GCS) < 15
- No functioning of the optic nerve or retina in both eyes
- Unable to open both eyes
- Non communicating patients e.g. aphasia (incompetent patients)
- Unable to cooperate to the physical examinations
- Less than 2 weeks of hospitalization in the rehabilitation department
- If the sub investigator finds the study participant unfit to conduct the investigations
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Glostrup Municipality, 2600
About this study
The purpose of this study is to investigate the impact of exposure to ergonomic circadian light on physiological and mental parameters in stroke patients admitted for rehabilitation.
Read the detailed description
Stroke annually affects approximately 12,000 Danes and there are approximately 50,000 living persons with sequelae after stroke in Denmark. Stroke is the major cause of acquired cerebral disability among adults and the second most common cause of dementia and the third leading cause of death.
Besides the acute stroke treatment, an effective rehabilitation program is necessary for optimal recovery. A prerequisite for this is that stroke patients are able to contribute optimally to the training, however, changes in the sleep pattern and disturbed circadian rhythm may exert negative effects.
Little is known about circadian disturbances in relation to rehabilitations and which consequences it may have on the physiological and mental levels.
The investigators will investigate the following hypotheses:
A: Ergonomic circadian light improves well-being and fatigue in post-stroke patients compared with a control group receiving standard light facilities.
B: Ergonomic circadian light induces improve sleep-wake cycle and circadian rhythm in post-stroke patients compared with a control group receiving standard light facilities.
C: Ergonomic circadian light induces reduction in depression and anxiety in post-stroke patients compared with a control group receiving standard light facilities.
D: Ergonomic circadian light improves the cognitive function in post-stroke patients compared with a control group receiving standard light facilities.
E: Ergonomic circadian light induces reduction in autonomic dysfunction in post-stroke patients compared with a control group receiving standard light facilities.
F: Ergonomic circadian light will regulate circadian rhythm specific blood tests in post-stroke patients compared with a control group receiving standard light facilities.
From the acute stroke unit the patients will be random transferred to two rehabilitation units where the will be the intervention unit with the circadian light installed and a control unit with conventional light.
At the inclusion, patients will be assessed by the following interventions mentioned below, which again will be evaluated at discharge. The incompetent patients to these interventions must abstain.
The numbers of patients who are expected to be included are 110 calculated with 25% dropout resulting in approximately 80 patients.
All patients who are found suitable for admission to the two rehabilitation departments will be listed. If a patient is not suitable for inclusion in the study the reason will be described and published.
During hospitalization on the rehabilitation unit following tests/interventions will be performed on the patients:
- Stroke classification
- Sleep physiology
- Sleep biochemistry
- Test for depression
- Test for cognitive function
- Test for anxiety
- Test Fatigue
- Testing for sleep quality
- Test for Quality of well being
- Chronotype classification
- Autonomic dysfunction
- Status of physical rehabilitation
- Functional MRI Resting state
- Circadian blood samples
- Ophthalmological examination
- Conditions
- Stroke, Sleep Apnea Syndromes, Depression, Anxiety
- Being tested
- Circadian Light luminaries
- Keywords
- Depression, Anxiety, Stroke, Cerebral Infarction, Sleep disorders, Circadian Rhythm disorders, Circadian Light, Light therapy, Melatonin, Sleep, Sleep apnea, Coagulation disturbances, Bone metabolism, Rehabilitation, Mood disorders, Mental disorders, Neurologic Manifestations, Signs and Symptoms Cerebrovascular Disorders, Brain Diseases, Vascular Disease
- Medical subject headings
- Stroke, Sleep Apnea Syndromes, Depression, Anxiety Disorders, Cerebral Infarction, Sleep Wake Disorders, Chronobiology Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Light luminariesDevice
Also called Chroma Viso, Ergonomic
The light is programmed to have the desired light intensity (lux), color temperature (Kelvin) and wavelength (nm) according to the knowledge about the phase-response curve.
| Study group | Role | What they receive |
|---|---|---|
| Control department | No intervention | The control department where the conventional light is installed. |
| Circadian Light luminaries | Experimental | The department where the special circadian light is installed. The light is programmed to have the desired light intensity (lux), color temperature (Kelvin) and wavelength (nm) according to the knowledge about the phase-response curve. Receives: Device: Circadian Light luminaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
well-being
The test will be performed at the admission for the rehabilitation unit and at discharged.
Well-being and fatigue is according to WHO-5 well-being scale, Multidimensional Fatigue Inventory-20 (MFI-20), Visual Analog Scala for fatigue.
Measured: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Depression
The test will be performed at the admission for the rehabilitation unit and at discharged.
Mild, moderate or severe depression according to Hamilton-D6 (HAM-D6), Major Depression Inventory (MDI) or Hospital Anxiety and Depression Scale (HADS).
Measured: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Anxiety
The test will be performed at the admission for the rehabilitation unit and at discharged.
Anxiety according to HADS.
Measured: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Circadian rhythm specific blood marker
Measured: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Sleep and sleep-wake cycle
The test will be performed at the admission for the rehabilitation unit and at discharged.
Sleep will be measured according to Polysomnography, Actigraph, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale.
Measured: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Secondary outcomes (2)
Cognitive function
The test will be performed at the admission for the rehabilitation unit and at discharged.
Level of cognitive function is according to Montreal Cognitive Assessment (MoCA), Trail Marking Test (TMT), and Confusion Assessment Method.
Measured: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Autonomic function
The test will be performed at the admission for the rehabilitation unit and at discharged.
autonomic dysfunction will be measured according to Polysomnography by heart rate and blod pressure.
Measured: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completion15 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helle Klingenberg Iversen, MD, DmSc, Glostrup University Hospital, Copenhagen
- Investigators
- Helle K Iversen, MD, DMSc, Study chair, Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.Poul Jennum, MD, DMSc, Study director, Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital.Anders S West, MD, Principal investigator, Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186392
- Sponsor's protocol ID
- H-4-2013-114
- Status last verified
- Dec 2017
- First submitted
- 3 Jun 2014
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit
- ClinicalTrials.gov ID
- NCT02186392
- Acronym / sponsor ID
- H-4-2013-114
- Conditions
- Stroke, Sleep Apnea Syndromes, Depression, Anxiety
- Keywords
- Depression, Anxiety, Stroke, Cerebral Infarction, Sleep disorders, Circadian Rhythm disorders, Circadian Light, Light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 10 Jul 2014 (estimated)
- 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 purpose of this study is to investigate the impact of exposure to ergonomic circadian light on physiological and mental parameters in stroke patients admitted for rehabilitation.
Detailed description
Stroke annually affects approximately 12,000 Danes and there are approximately 50,000 living persons with sequelae after stroke in Denmark. Stroke is the major cause of acquired cerebral disability among adults and the second most common cause of dementia and the third leading cause of death.
Besides the acute stroke treatment, an effective rehabilitation program is necessary for optimal recovery. A prerequisite for this is that stroke patients are able to contribute optimally to the training, however, changes in the sleep pattern and disturbed circadian rhythm may exert negative effects.
Little is known about circadian disturbances in relation to rehabilitations and which consequences it may have on the physiological and mental levels.
The investigators will investigate the following hypotheses:
A: Ergonomic circadian light improves well-being and fatigue in post-stroke patients compared with a control group receiving standard light facilities.
B: Ergonomic circadian light induces improve sleep-wake cycle and circadian rhythm in post-stroke patients compared with a control group receiving standard light facilities.
C: Ergonomic circadian light induces reduction in depression and anxiety in post-stroke patients compared with a control group receiving standard light facilities.
D: Ergonomic circadian light improves the cognitive function in post-stroke patients compared with a control group receiving standard light facilities.
E: Ergonomic circadian light induces reduction in autonomic dysfunction in post-stroke patients compared with a control group receiving standard light facilities.
F: Ergonomic circadian light will regulate circadian rhythm specific blood tests in post-stroke patients compared with a control group receiving standard light facilities.
From the acute stroke unit the patients will be random transferred to two rehabilitation units where the will be the intervention unit with the circadian light installed and a control unit with conventional light.
At the inclusion, patients will be assessed by the following interventions mentioned below, which again will be evaluated at discharge. The incompetent patients to these interventions must abstain.
The numbers of patients who are expected to be included are 110 calculated with 25% dropout resulting in approximately 80 patients.
All patients who are found suitable for admission to the two rehabilitation departments will be listed. If a patient is not suitable for inclusion in the study the reason will be described and published.
During hospitalization on the rehabilitation unit following tests/interventions will be performed on the patients:
- Stroke classification
- Sleep physiology
- Sleep biochemistry
- Test for depression
- Test for cognitive function
- Test for anxiety
- Test Fatigue
- Testing for sleep quality
- Test for Quality of well being
- Chronotype classification
- Autonomic dysfunction
- Status of physical rehabilitation
- Functional MRI Resting state
- Circadian blood samples
- Ophthalmological examination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control department | No intervention | –The control department where the conventional light is installed. |
| Circadian Light luminaries | Experimental | Device: Circadian Light luminariesThe department where the special circadian light is installed. The light is programmed to have the desired light intensity (lux), color temperature (Kelvin) and wavelength (nm) according to the knowledge about the phase-response curve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients evaluated as candidates to the rehabilitation units from May 1th 2014 to May 1th 2015.
Key exclusion criteria (7 listed)
- Glasgow Coma Scale (GCS) < 15
- No functioning of the optic nerve or retina in both eyes
- Unable to open both eyes
- Non communicating patients e.g. aphasia (incompetent patients)
- Unable to cooperate to the physical examinations
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 |
|---|---|---|
| Circadian Light luminariesAlso: Chroma Viso, ErgonomicThe light is programmed to have the desired light intensity (lux), color temperature (Kelvin) and wavelength (nm) according to the knowledge about the phase-response curve. | Device | Circadian Light luminaries |
Primary outcome
well-being
Time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
The test will be performed at the admission for the rehabilitation unit and at discharged. Well-being and fatigue is according to WHO-5 well-being scale, Multidimensional Fatigue Inventory-20 (MFI-20), Visual Analog Scala for fatigue.
Depression
Time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
The test will be performed at the admission for the rehabilitation unit and at discharged. Mild, moderate or severe depression according to Hamilton-D6 (HAM-D6), Major Depression Inventory (MDI) or Hospital Anxiety and Depression Scale (HADS).
Anxiety
Time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
The test will be performed at the admission for the rehabilitation unit and at discharged. Anxiety according to HADS.
Circadian rhythm specific blood marker
Time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Sleep and sleep-wake cycle
Time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
The test will be performed at the admission for the rehabilitation unit and at discharged. Sleep will be measured according to Polysomnography, Actigraph, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale.
2 secondary outcomes
Cognitive function
Time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 4 weeks.
Autonomic function
Time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 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 22 Dec 2017.
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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.
Helle K Iversen, MD, DMSc study chair
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Poul Jennum, MD, DMSc study director
Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital.
Anders S West, MD principal investigator
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Light luminaries in people with Stroke and Sleep Apnea Syndromes, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 1 inclusion and 7 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 22 Dec 2017. 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 Denmark. 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. 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?
well-being (time frame: The participants will be tested at the inklusion (1-2 days before admission to the rehabilitation unit) and at discharge. A hospital stay with an average duration of about 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?
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 22 Dec 2017.