Post Stroke DepressionNCT06922409
The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation.
A study testing Naturalistic Light Intervention in people with Post Stroke Depression and Post Stroke Fatigue, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Background: Light is the most important regulator of circadian rhythm. Naturalistic light, which contains the spectrum of sunlight throughout the day, has been shown to have a positive impact on mental states such as depression and fatigue in stroke and other diseases requiring long-term hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke Depression, Post Stroke Fatigue, Circadian Dysregulation
- What is being tested?
- Naturalistic Light Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2025to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 scoring moderate-severe fatigue and/or depression OR NO fatigue and/or depressione which are evaluated as candidates for the rehabilitation unit.
Who cannot join
- GCS < 15
- No functioning nervus opticus or retina in both eyes
- Unable to open both eyes
- Non communicating patients e.g. severe aphasia (incompetent patients)
- Unable to cooperate to the physical examinations
- Less than 10 days of hospitalization in the rehabilitation department
- Claustrophobia
- If the sub investigator finds the study participant unfit to conduct the investigations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Faculty of Health and Medical Sciences - University of Copenhagen
Glostrup Municipality, Capital Region, 2600
Anders S West, MD, PhD, +4521748587, anders.sode.west@regionh.dk
Helle K Iversen, MD, DMSc, helle.klingenberg.iversen@regionh.dk
About this study
Official title: The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation
Background:
Light is the most important regulator of circadian rhythm. Naturalistic light, which contains the spectrum of sunlight throughout the day, has been shown to have a positive impact on mental states such as depression and fatigue in stroke and other diseases requiring long-term hospitalization.
Read more
Depression and fatigue are very common complications after stroke, with a frequency of 30% and 85%, respectively. Both are significantly related to reduced quality of life and early death. Both the causes and pathophysiology behind these complications are unknown, but it is assumed that disturbances (inflammation and cell death) in brain areas and brain networks related to arousal, sleep, circadian rhythm, and the frontal lobe play a role.
The hypothesis is that it is possible to detect changes in brain networks related to depression and fatigue by MRI, and that naturalistic light will affect these changes.
Method:
Stroke patients requiring a minimum of 10 days of rehabilitation are transferred to a neurorehabilitation unit with naturalistic lighting.
Examination:
Validated tests for fatigue, depression, sleep and cognitive functions.
Pathophysiological studies:
- MRI focusing on cerebral blood flow, metabolism, and cerebral networks.
- Spinal fluid analyses for hormones and markers involved in immunological response as well as wakefulness/arousal and depression.
- Sleep assessments.
Read the detailed description
OBJECTIVE AND PURPOSE
To investigate the effect of naturalistic lighting (i.e., artificial light imitating the sunlight rhythm and spectrum) on depression, sleep, executive cognition, and fatigue in a hospital setting among patients admitted for post-stroke rehabilitation. The effect is planned to be measured by questionnaires, MRI modalities, and CSV markers for localizing inflammation, levels of hypocretin and sleep. The hypothesis is based on the findings from the previously light trial.
BACKGROUND INFORMATION
Stroke annually affects approximately 12,000 Danes and there are approximately 75,000 stroke survivors with sequelae after stroke. Stroke is the major cause of acquired cerebral disability among adults, the second most common cause of dementia and the fourth leading cause of death. An effective rehabilitation program is mandatory for optimal recovery; however, post stroke complications in relation to circadian rhythm disruptions counteracts this.
The circadian rhythm association The circadian response is especially sensitive of short-wavelength blue light because of the blue light-sensitive photopigment Melanopsin in the retina, which communicates with the suprachiasmatic nucleus (SCN) through the retinohypothalamic tract (RHT). As sunlight contains blue light, it is essential to imitate the stimulation during the day to entrain the circadian rhythm. Active, working people are exposed to bright sunlight during the day to regulate their circadian rhythm but in hospitals, rehabilitation patients are often indoors and receive only bright light through the hospital window and disturbing light in night time by normal light bulbs.
The previously light trial A light trial was conducted in 2014-2015 with the title "The effect of naturalistic light in stroke patients" (Danish scientific ethics committee (H-4-2013-114) and the Danish Data Protection Agency (2007-58-0015). ClinicalTrials.gov Identifier: NCT02186392.). The study was a large project investigating the effect of naturalistic light on human health measured by psychological parameters, biochemical parameters, fatigue and sleep.
The trial was carried out in the Stroke Rehabilitation unit, Department of Neurology, Rigshospitalet, Copenhagen. The study was a randomized controlled study with two arms. Stroke patients at the acute stroke unit were randomized to either an intervention rehabilitation unit (IU) equipped with naturalistic lighting or a control rehabilitation unit (CU) with standard lighting.
One of the main findings was a significant decrease depressive mood by 51.9%, decreased fatigue by 20.6%, decreased anxiety by 28,6%, increased rested feeling by 41,6% and increased well-being by 46,5%. Furthermore, the study found increased serum cortisol morning levels and increased levels of melatonin and rhythmicity in patients exposed to naturalistic light during admission. No difference in cognition, sleepiness and sleep quality were detected. In papers that are currently undergoing peer-review have showed disturbed endocrinological parameters after stroke, but no effect of the naturalistic light indicating that light may be a central circadian regulator.
Light and depression A proximately one third of stroke patients (30-50%) suffer of Post Stroke Depression (PSD). PSD has been significantly associated with increased mortality approx. 50%, taking risk factors into account. The mortality is reduced to 20% by treatment vs 65% without treatment. PSD is also associated to new stroke incidence, reduced participation in rehabilitation (54%), reduced cognitive function, double the number of suicides, increased use of health services and decreased activity of daily living.
The circadian rhythm is responsible for the circadian expression and activity of several neurotransmitters and circadian-controlled genes known as clock genes.
Based on our previous results and the literature, naturalistic light appears to reduce the depressive mood in the post stroke brain. However, the pathophysiology of PSD is still unclear and there is still no clear evidence linking brain lesions to PSD. Therefore, investigating cerebral serotonin transporter binding, the brains activity and functional network connectivity, especially output from SCN, measured by brain scans may obtain knowledge about the source of the PSD.
Post Stroke Fatigue Post stroke fatigue (PSF) is defined by extreme tiredness resulting from mental or physical exertion or illness and affect 25% to 85% of stroke patients (75% in the previously described light study). PSF reported by forty percent of stroke patients to be the worst or one of the worst sequelae after stroke.
Complications after PSF, has been correlated with the following: reduced functional outcome, decrease in activities of daily living (ADL) and mortality.
The pathophysiological and anatomical explanation behind PSF is like PSD not fully understood. However, brain structures that have been found to be significantly associated to PSF are the thalamus, brainstem, subcortical region and basal ganglia which are known to have connections to the SCN, why SCN may be an important stimulator.
Cognitive executive functions The prevalence of post stroke cognitive impairment varies between studies but range from 7.5% to 72%. It has been proven that the cognitive function in humans becomes impaired with disturbance of the circadian rhythm. The physiology behind circadian disturbance and cognitive dysfunction is not completely known, but brain regions outside of the SCN may be part of the mechanism where Diffusion tensor tractography (DTT) appear to visualize the structures.
In relation to the above, cerebral hypoperfusion may also be relevant to examine as reduced cognition, like depression, has been correlated to regional cerebral hypoperfusion.
Naturalistic light as an Intervention A 24-hour naturalistic lighting scheme is already implemented in all areas and rooms in unit N35 at Rigshospitalet Glostrup with a computer-controlled lighting scheme (ChromaViso, Denmark). The naturalistic lighting scheme is constantly running.
METHOD
Experimental participants and the Intervention during hospitalization The intervention group and the control group are stroke patients admitted to the acute stroke unit and considered suitable for admission in the rehabilitation's unit, Department of Neurology, Rigshospitalet Glostrup during the period February 1th 2025 to February 1th 2027.
Patients admitted at the acute stroke unit will be screened for fatigue and depression. The patients will be selected for the study by the present and absent of moderate-severe depression and fatigue (50%+50%). The control group will be patients without any symptoms of depression and fatigue. The intervention group will be patients scored to have moderate-severe depression and fatigue. All patients must be selected to neurorehabilitation in our rehabilitation unit for a minimum of 10 days which include rehabilitation through physiotherapy, occupational therapist, speech therapist or a neuropsychologist. The rehabilitation unit is the intervention unit where the Naturalistic light is installed. In the acute stroke unit, the patient receives the normal initial assessment, blood samples, physical neurological somatic examination, and the paraclinical examination program after stroke.
At the inclusion, patients will be assessed by the following assessments mentioned below, which again will be evaluated at discharge.
The numbers of patients who are expected to be included in total are 45 patients, which is estimated to be 42 enrolled and completed patients after dropout (i.e. 21 patients in each group). In addition, same makers from blood and CSF will be collected from 10 healthy subjects.
Trial Design Case-control study with two arms. The number of patients who are expected to be included are 45.
Assessments
- Stroke classification scales
- Questionnaires and physiological tests of sleep quality
- Questionnaires for depression
- Test for executive cognitive function performed by neuropsychologist
- Test for fatigue
- Testing for mobilization level and status of physical rehabilitation
- Cerebrospinal fluid (CSF): Special inflammation makers, Neuronal injury and neurotransmitters in relation to sleep and depression.
- MRI perfusion and network sequences
STATISTICS
Power and sample size analysis 5% cut-off point.
Depression and Fatigue:
Experience from our previous trials, we estimate that at least 40 patients must be included regarding the Multidimensional Fatigue Inventory (MFI-20) and Major depression inventory test (MDI).
MRI:
The power calculation is based on literature using different toolboxes for MRI power calculations e.g www.neuropowertools.org. With a 5% cut-off point and power on 80% up against various test for multiple testing, must the included number of subjects be above 40.
Sleepiness and sleep quality:
It was not possible to detect any significance in our previously trial. However, the lack of significance may also be related to the patent cohort due to impaired sleep network as a result of the stroke, why a significant outcome may be found in subgroups and therefore not a power problem in this trail.
- Being tested
- Naturalistic Light Intervention
- Keywords
- circadian rhythm disruption, Stroke, Post Stroke Depression, Post Stroke Fatigue, Light therapy, Circadian Light
- Medical subject headings
- Chronobiology Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturalistic Light InterventionDevice
Also called Circadiain Light Intervention, Dynamic Light Intervention
Naturalistic light as an Intervention A 24-hour naturalistic lighting scheme is implemented in all areas and rooms in the unit at Rigshospitalet Glostrup with a computer-controlled lighting scheme (ChromaViso, Denmark). The naturalistic lighting scheme is constantly running. The lighting imitate the sunlight rhythm following the principles of Lucas et al.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-severe depression or/and fatigue | Active comparator | Naturalistic Light Intervention Receives: Device: Naturalistic Light Intervention |
| No measured depression or/and fatigue | Active comparator | Naturalistic Light Intervention Receives: Device: Naturalistic Light Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue and depression
Primary hypothesis: Naturalistic light reduce the major depression inventory questionnaire score and multidimensional fatigue inventory questionnaire score from baseline til discharge. Mood-related network will too show positive changes measured by whole brain resting-state connectivity in post-stroke patients compared with a control group without fatigue and depression.
Measured: From admission at the rehabilitation unit to the time of discharge aprox. 10 days.
Secondary outcomes (4)
Cognitive function
Secondary hypothesis: Naturalistic light improves executive cognitive function and processing speed in test included in the Neuropsychology assessments (Verbal fluency, 1 minute each per test: Category fluency (animals) and lexical fluency (s words and a words), System Digit Modalities Test (SDMT), and Stroop test) and furthermore modifies cognitive related network activation measured by fMRI in post-stroke patients compared with a control group without cognitive impairment.
Measured: From admission to the neurorehabilitation unit to the time of discharge aprox 10 days..
Sleep quality
Secondary hypothesis: Naturalistic light improves sleep quality from baseline to discharge measured by polysomnography and Pittsburgh Sleep Quality Index questionnaire in post-stroke patients compared with a control group without poor sleep quality.
Measured: From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..
Hypocretin
Secondary hypothesis: Naturalistic light increase hypocretin levels from baseline to discharge in post stroke patients with measured fatigue and sleepiness compared to a control group without fatigue and sleepiness.
Measured: From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..
CFS inflammation
Secondary hypothesis: The severity of post stroke fatigue and post stroke depression is associated to the level of markers related to cerebral inflammation based on measured CFS inflammation and naturalistic light will decrease this inflammation compared to a control group without fatigue and depression.
Measured: From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start10 Apr 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jan 2030 (estimated)
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 Post Stroke DepressionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Study Design: Case-control study Study description: Patients admitted at the acute stroke unit will be screened for fatigue and depression. The patients will be selected for the study by the present and absent of moderate-severe depression and fatigue (50%+50%). The control group will be patients without any symptoms of depression and fatigue. The intervention group will be patients scored to have moderate-severe depression and fatigue. All patients must be selected to neurorehabilitation for a minimum of 10 days where the intervention (naturalistic light) is installed.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Chromaviso A/S
- Responsible party
- Principal investigator, Anders Sode West, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Anders Sode West, MD, PhD, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922409
- Sponsor's protocol ID
- H-22014644
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The confidentiality of this data is not yet known.
Publications
West A, Jennum P, Simonsen SA, Sander B, Pavlova M, Iversen HK. Impact of naturalistic lighting on hospitalized stroke patients in a rehabilitation unit: Design and measurement. Chronobiol Int. 2017;34(6):687-697. doi: 10.1080/07420528.2017.1314300. Epub 2017 Apr 21.
PubMed 28430522
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation
- ClinicalTrials.gov ID
- NCT06922409
- Acronym / sponsor ID
- H-22014644
- Keywords
- circadian rhythm disruption, Stroke, Post Stroke Depression, Post Stroke Fatigue, Light therapy, Circadian Light
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Chromaviso A/S
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 10 Apr 2025 (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.
Background:
Light is the most important regulator of circadian rhythm. Naturalistic light, which contains the spectrum of sunlight throughout the day, has been shown to have a positive impact on mental states such as depression and fatigue in stroke and other diseases requiring long-term hospitalization.
Depression and fatigue are very common complications after stroke, with a frequency of 30% and 85%, respectively. Both are significantly related to reduced quality of life and early death. Both the causes and pathophysiology behind these complications are unknown, but it is assumed that disturbances (inflammation and cell death) in brain areas and brain networks related to arousal, sleep, circadian rhythm, and the frontal lobe play a role.
The hypothesis is that it is possible to detect changes in brain networks related to depression and fatigue by MRI, and that naturalistic light will affect these changes.
Method:
Stroke patients requiring a minimum of 10 days of rehabilitation are transferred to a neurorehabilitation unit with naturalistic lighting.
Examination:
Validated tests for fatigue, depression, sleep and cognitive functions.
Pathophysiological studies:
- MRI focusing on cerebral blood flow, metabolism, and cerebral networks.
- Spinal fluid analyses for hormones and markers involved in immunological response as well as wakefulness/arousal and depression.
- Sleep assessments.
Detailed description
OBJECTIVE AND PURPOSE
To investigate the effect of naturalistic lighting (i.e., artificial light imitating the sunlight rhythm and spectrum) on depression, sleep, executive cognition, and fatigue in a hospital setting among patients admitted for post-stroke rehabilitation. The effect is planned to be measured by questionnaires, MRI modalities, and CSV markers for localizing inflammation, levels of hypocretin and sleep. The hypothesis is based on the findings from the previously light trial.
BACKGROUND INFORMATION
Stroke annually affects approximately 12,000 Danes and there are approximately 75,000 stroke survivors with sequelae after stroke. Stroke is the major cause of acquired cerebral disability among adults, the second most common cause of dementia and the fourth leading cause of death. An effective rehabilitation program is mandatory for optimal recovery; however, post stroke complications in relation to circadian rhythm disruptions counteracts this.
The circadian rhythm association The circadian response is especially sensitive of short-wavelength blue light because of the blue light-sensitive photopigment Melanopsin in the retina, which communicates with the suprachiasmatic nucleus (SCN) through the retinohypothalamic tract (RHT). As sunlight contains blue light, it is essential to imitate the stimulation during the day to entrain the circadian rhythm. Active, working people are exposed to bright sunlight during the day to regulate their circadian rhythm but in hospitals, rehabilitation patients are often indoors and receive only bright light through the hospital window and disturbing light in night time by normal light bulbs.
The previously light trial A light trial was conducted in 2014-2015 with the title "The effect of naturalistic light in stroke patients" (Danish scientific ethics committee (H-4-2013-114) and the Danish Data Protection Agency (2007-58-0015). ClinicalTrials.gov Identifier: NCT02186392.). The study was a large project investigating the effect of naturalistic light on human health measured by psychological parameters, biochemical parameters, fatigue and sleep.
The trial was carried out in the Stroke Rehabilitation unit, Department of Neurology, Rigshospitalet, Copenhagen. The study was a randomized controlled study with two arms. Stroke patients at the acute stroke unit were randomized to either an intervention rehabilitation unit (IU) equipped with naturalistic lighting or a control rehabilitation unit (CU) with standard lighting.
One of the main findings was a significant decrease depressive mood by 51.9%, decreased fatigue by 20.6%, decreased anxiety by 28,6%, increased rested feeling by 41,6% and increased well-being by 46,5%. Furthermore, the study found increased serum cortisol morning levels and increased levels of melatonin and rhythmicity in patients exposed to naturalistic light during admission. No difference in cognition, sleepiness and sleep quality were detected. In papers that are currently undergoing peer-review have showed disturbed endocrinological parameters after stroke, but no effect of the naturalistic light indicating that light may be a central circadian regulator.
Light and depression A proximately one third of stroke patients (30-50%) suffer of Post Stroke Depression (PSD). PSD has been significantly associated with increased mortality approx. 50%, taking risk factors into account. The mortality is reduced to 20% by treatment vs 65% without treatment. PSD is also associated to new stroke incidence, reduced participation in rehabilitation (54%), reduced cognitive function, double the number of suicides, increased use of health services and decreased activity of daily living.
The circadian rhythm is responsible for the circadian expression and activity of several neurotransmitters and circadian-controlled genes known as clock genes.
Based on our previous results and the literature, naturalistic light appears to reduce the depressive mood in the post stroke brain. However, the pathophysiology of PSD is still unclear and there is still no clear evidence linking brain lesions to PSD. Therefore, investigating cerebral serotonin transporter binding, the brains activity and functional network connectivity, especially output from SCN, measured by brain scans may obtain knowledge about the source of the PSD.
Post Stroke Fatigue Post stroke fatigue (PSF) is defined by extreme tiredness resulting from mental or physical exertion or illness and affect 25% to 85% of stroke patients (75% in the previously described light study). PSF reported by forty percent of stroke patients to be the worst or one of the worst sequelae after stroke.
Complications after PSF, has been correlated with the following: reduced functional outcome, decrease in activities of daily living (ADL) and mortality.
The pathophysiological and anatomical explanation behind PSF is like PSD not fully understood. However, brain structures that have been found to be significantly associated to PSF are the thalamus, brainstem, subcortical region and basal ganglia which are known to have connections to the SCN, why SCN may be an important stimulator.
Cognitive executive functions The prevalence of post stroke cognitive impairment varies between studies but range from 7.5% to 72%. It has been proven that the cognitive function in humans becomes impaired with disturbance of the circadian rhythm. The physiology behind circadian disturbance and cognitive dysfunction is not completely known, but brain regions outside of the SCN may be part of the mechanism where Diffusion tensor tractography (DTT) appear to visualize the structures.
In relation to the above, cerebral hypoperfusion may also be relevant to examine as reduced cognition, like depression, has been correlated to regional cerebral hypoperfusion.
Naturalistic light as an Intervention A 24-hour naturalistic lighting scheme is already implemented in all areas and rooms in unit N35 at Rigshospitalet Glostrup with a computer-controlled lighting scheme (ChromaViso, Denmark). The naturalistic lighting scheme is constantly running.
METHOD
Experimental participants and the Intervention during hospitalization The intervention group and the control group are stroke patients admitted to the acute stroke unit and considered suitable for admission in the rehabilitation's unit, Department of Neurology, Rigshospitalet Glostrup during the period February 1th 2025 to February 1th 2027.
Patients admitted at the acute stroke unit will be screened for fatigue and depression. The patients will be selected for the study by the present and absent of moderate-severe depression and fatigue (50%+50%). The control group will be patients without any symptoms of depression and fatigue. The intervention group will be patients scored to have moderate-severe depression and fatigue. All patients must be selected to neurorehabilitation in our rehabilitation unit for a minimum of 10 days which include rehabilitation through physiotherapy, occupational therapist, speech therapist or a neuropsychologist. The rehabilitation unit is the intervention unit where the Naturalistic light is installed. In the acute stroke unit, the patient receives the normal initial assessment, blood samples, physical neurological somatic examination, and the paraclinical examination program after stroke.
At the inclusion, patients will be assessed by the following assessments mentioned below, which again will be evaluated at discharge.
The numbers of patients who are expected to be included in total are 45 patients, which is estimated to be 42 enrolled and completed patients after dropout (i.e. 21 patients in each group). In addition, same makers from blood and CSF will be collected from 10 healthy subjects.
Trial Design Case-control study with two arms. The number of patients who are expected to be included are 45.
Assessments
- Stroke classification scales
- Questionnaires and physiological tests of sleep quality
- Questionnaires for depression
- Test for executive cognitive function performed by neuropsychologist
- Test for fatigue
- Testing for mobilization level and status of physical rehabilitation
- Cerebrospinal fluid (CSF): Special inflammation makers, Neuronal injury and neurotransmitters in relation to sleep and depression.
- MRI perfusion and network sequences
STATISTICS
Power and sample size analysis 5% cut-off point.
Depression and Fatigue:
Experience from our previous trials, we estimate that at least 40 patients must be included regarding the Multidimensional Fatigue Inventory (MFI-20) and Major depression inventory test (MDI).
MRI:
The power calculation is based on literature using different toolboxes for MRI power calculations e.g www.neuropowertools.org. With a 5% cut-off point and power on 80% up against various test for multiple testing, must the included number of subjects be above 40.
Sleepiness and sleep quality:
It was not possible to detect any significance in our previously trial. However, the lack of significance may also be related to the patent cohort due to impaired sleep network as a result of the stroke, why a significant outcome may be found in subgroups and therefore not a power problem in this trail.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Design: Case-control study Study description: Patients admitted at the acute stroke unit will be screened for fatigue and depression. The patients will be selected for the study by the present and absent of moderate-severe depression and fatigue (50%+50%). The control group will be patients without any symptoms of depression and fatigue. The intervention group will be patients scored to have moderate-severe depression and fatigue. All patients must be selected to neurorehabilitation for a minimum of 10 days where the intervention (naturalistic light) is installed.
| Arm | Type | Receives |
|---|---|---|
| Moderate-severe depression or/and fatigue | Active comparator | Device: Naturalistic Light InterventionNaturalistic Light Intervention |
| No measured depression or/and fatigue | Active comparator | Device: Naturalistic Light InterventionNaturalistic Light Intervention |
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 scoring moderate-severe fatigue and/or depression OR NO fatigue and/or depressione which are evaluated as candidates for the rehabilitation unit.
Key exclusion criteria (8 listed)
- GCS < 15
- No functioning nervus opticus or retina in both eyes
- Unable to open both eyes
- Non communicating patients e.g. severe 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 |
|---|---|---|
| Naturalistic Light InterventionAlso: Circadiain Light Intervention, Dynamic Light InterventionNaturalistic light as an Intervention A 24-hour naturalistic lighting scheme is implemented in all areas and rooms in the unit at Rigshospitalet Glostrup with a computer-controlled lighting scheme (ChromaViso, Denmark). The naturalistic lighting scheme is constantly running. The lighting imitate the sunlight rhythm following the principles of Lucas et al. | Device | Moderate-severe depression or/and fatigue, No measured depression or/and fatigue |
Primary outcome
Fatigue and depression
Time frame: From admission at the rehabilitation unit to the time of discharge aprox. 10 days.
Primary hypothesis: Naturalistic light reduce the major depression inventory questionnaire score and multidimensional fatigue inventory questionnaire score from baseline til discharge. Mood-related network will too show positive changes measured by whole brain resting-state connectivity in post-stroke patients compared with a control group without fatigue and depression.
4 secondary outcomes
Cognitive function
Time frame: From admission to the neurorehabilitation unit to the time of discharge aprox 10 days..
Sleep quality
Time frame: From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..
Hypocretin
Time frame: From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..
CFS inflammation
Time frame: From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 28430522West A, Jennum P, Simonsen SA, Sander B, Pavlova M, Iversen HK. Impact of naturalistic lighting on hospitalized stroke patients in a rehabilitation unit: Design and measurement. Chronobiol Int. 2017;34(6):687-697. doi: 10.1080/07420528.2017.1314300. Epub 2017 Apr 21.
- Individual participant dataSharing planned: Undecided. The confidentiality of this data is not yet known.
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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.
Anders Sode West, MD, PhD principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naturalistic Light Intervention in people with Post Stroke Depression and Post Stroke Fatigue, run by Copenhagen University Hospital, Rigshospitalet 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 8 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: looking for participants now, as of the sponsor's last update on 15 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Sode West, MD, PhD. (+4538634051, anders.sode.west@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue and depression (time frame: From admission at the rehabilitation unit to the time of discharge aprox. 10 days.). 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 NCT06922409, 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 15 Apr 2025.