The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit

Active, not recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • Circadian Light luminaries Device
    Other Names: Chroma Viso; Ergonomic
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Circadian Light luminaries
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary well-being 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. No
Primary Depression 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. No
Primary Anxiety 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. No
Primary 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. No
Primary Sleep and sleep-wake cycle 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. No
Secondary Cognitive function 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. No
Secondary Autonomic function 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. No

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