The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit
NCT ID: NCT02186392
Last Updated: 2017-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2014-05-31
2016-08-15
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control department
The control department where the conventional light is installed.
No interventions assigned to this group
Circadian Light luminaries
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.
Circadian Light luminaries
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.
Interventions
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Circadian Light luminaries
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Helle Klingenberg Iversen, MD, DmSc
MD, DMSc
Principal Investigators
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Helle K Iversen, MD, DMSc
Role: STUDY_CHAIR
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Poul Jennum, MD, DMSc
Role: STUDY_DIRECTOR
Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital.
Anders S West, MD
Role: PRINCIPAL_INVESTIGATOR
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Locations
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Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Glostrup Municipality, , Denmark
Countries
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Other Identifiers
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H-4-2013-114
Identifier Type: -
Identifier Source: org_study_id