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

Primary Purpose

Stroke, Sleep Apnea Syndromes, Depression

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Circadian Light luminaries
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring 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, Brain Infarction, Brain Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients evaluated as candidates to the rehabilitation units from May 1th 2014 to May 1th 2015.

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control department

Circadian Light luminaries

Arm Description

The control department where the conventional light is installed.

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.

Outcomes

Primary Outcome Measures

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.
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).
Anxiety
The test will be performed at the admission for the rehabilitation unit and at discharged. Anxiety according to HADS.
Circadian rhythm specific blood marker
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 3, 2014
Last Updated
December 20, 2017
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02186392
Brief Title
The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit
Official Title
The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Sleep Apnea Syndromes, Depression, Anxiety
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, Brain Infarction, Brain Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control department
Arm Type
No Intervention
Arm Description
The control department where the conventional light is installed.
Arm Title
Circadian Light luminaries
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Circadian Light luminaries
Other Intervention Name(s)
Chroma Viso, Ergonomic
Intervention Description
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.
Primary Outcome Measure Information:
Title
well-being
Description
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.
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.
Title
Depression
Description
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).
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.
Title
Anxiety
Description
The test will be performed at the admission for the rehabilitation unit and at discharged. Anxiety according to HADS.
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.
Title
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.
Title
Sleep and sleep-wake cycle
Description
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.
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.
Secondary Outcome Measure Information:
Title
Cognitive function
Description
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.
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.
Title
Autonomic function
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Physical status
Description
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).
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.
Title
Stroke classification
Description
Stroke classification according to TOAST criteria and Oxfordshire criteria.
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.
Title
Ophthalmological status
Description
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.
Time Frame
during hospitalization in the rehabilitation unit.
Title
cause of death after stroke
Time Frame
assessed at follow-up during admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients evaluated as candidates to the rehabilitation units from May 1th 2014 to May 1th 2015. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle K Iversen, MD, DMSc
Organizational Affiliation
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Poul Jennum, MD, DMSc
Organizational Affiliation
Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anders S West, MD
Organizational Affiliation
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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

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