Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadian Light luminaries | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 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 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical status | The test will be performed at the admission for the rehabilitation unit and at discharged. Physical status/testing for mobilization will be according to Barthel Index, Motor Assessment Scale, 10-meters walk test, National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS). | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helle K Iversen, MD, DMSc | Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital. | Study Chair |
| Poul Jennum, MD, DMSc | Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital. | Study Director |
| Anders S West, MD | Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital. | Glostrup Municipality | 2600 | Denmark |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D012891 | Sleep Apnea Syndromes |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D002544 | Cerebral Infarction |
| D012893 | Sleep Wake Disorders |
| D021081 | Chronobiology Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D001927 | Brain Diseases |
| D014652 | Vascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. |
| Stroke classification | Stroke classification according to TOAST criteria and Oxfordshire criteria. | 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. |
| Ophthalmological status | Ophthalmological status will be measured according to optical coherence tomography, fundus photography, pupillometry, visual acuity, color vision, intraocular pressure, Slitlamp examination and grading of the lens. | during hospitalization in the rehabilitation unit. |
| cause of death after stroke | assessed at follow-up during admission |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012816 | Signs and Symptoms |