<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02186392</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2013-114</org_study_id>
    <nct_id>NCT02186392</nct_id>
  </id_info>
  <brief_title>The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit</brief_title>
  <official_title>The Impact of Ergonomic Circadian Light on Hospitalized Stroke Patients in a Rehabilitation Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glostrup University Hospital, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the impact of exposure to ergonomic circadian&#xD;
      light on physiological and mental parameters in stroke patients admitted for rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke annually affects approximately 12,000 Danes and there are approximately 50,000 living&#xD;
      persons with sequelae after stroke in Denmark. Stroke is the major cause of acquired cerebral&#xD;
      disability among adults and the second most common cause of dementia and the third leading&#xD;
      cause of death.&#xD;
&#xD;
      Besides the acute stroke treatment, an effective rehabilitation program is necessary for&#xD;
      optimal recovery. A prerequisite for this is that stroke patients are able to contribute&#xD;
      optimally to the training, however, changes in the sleep pattern and disturbed circadian&#xD;
      rhythm may exert negative effects.&#xD;
&#xD;
      Little is known about circadian disturbances in relation to rehabilitations and which&#xD;
      consequences it may have on the physiological and mental levels.&#xD;
&#xD;
      The investigators will investigate the following hypotheses:&#xD;
&#xD;
      A: Ergonomic circadian light improves well-being and fatigue in post-stroke patients compared&#xD;
      with a control group receiving standard light facilities.&#xD;
&#xD;
      B: Ergonomic circadian light induces improve sleep-wake cycle and circadian rhythm in&#xD;
      post-stroke patients compared with a control group receiving standard light facilities.&#xD;
&#xD;
      C: Ergonomic circadian light induces reduction in depression and anxiety in post-stroke&#xD;
      patients compared with a control group receiving standard light facilities.&#xD;
&#xD;
      D: Ergonomic circadian light improves the cognitive function in post-stroke patients compared&#xD;
      with a control group receiving standard light facilities.&#xD;
&#xD;
      E: Ergonomic circadian light induces reduction in autonomic dysfunction in post-stroke&#xD;
      patients compared with a control group receiving standard light facilities.&#xD;
&#xD;
      F: Ergonomic circadian light will regulate circadian rhythm specific blood tests in&#xD;
      post-stroke patients compared with a control group receiving standard light facilities.&#xD;
&#xD;
      From the acute stroke unit the patients will be random transferred to two rehabilitation&#xD;
      units where the will be the intervention unit with the circadian light installed and a&#xD;
      control unit with conventional light.&#xD;
&#xD;
      At the inclusion, patients will be assessed by the following interventions mentioned below,&#xD;
      which again will be evaluated at discharge. The incompetent patients to these interventions&#xD;
      must abstain.&#xD;
&#xD;
      The numbers of patients who are expected to be included are 110 calculated with 25% dropout&#xD;
      resulting in approximately 80 patients.&#xD;
&#xD;
      All patients who are found suitable for admission to the two rehabilitation departments will&#xD;
      be listed. If a patient is not suitable for inclusion in the study the reason will be&#xD;
      described and published.&#xD;
&#xD;
      During hospitalization on the rehabilitation unit following tests/interventions will be&#xD;
      performed on the patients:&#xD;
&#xD;
        -  Stroke classification&#xD;
&#xD;
        -  Sleep physiology&#xD;
&#xD;
        -  Sleep biochemistry&#xD;
&#xD;
        -  Test for depression&#xD;
&#xD;
        -  Test for cognitive function&#xD;
&#xD;
        -  Test for anxiety&#xD;
&#xD;
        -  Test Fatigue&#xD;
&#xD;
        -  Testing for sleep quality&#xD;
&#xD;
        -  Test for Quality of well being&#xD;
&#xD;
        -  Chronotype classification&#xD;
&#xD;
        -  Autonomic dysfunction&#xD;
&#xD;
        -  Status of physical rehabilitation&#xD;
&#xD;
        -  Functional MRI Resting state&#xD;
&#xD;
        -  Circadian blood samples&#xD;
&#xD;
        -  Ophthalmological examination&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">August 15, 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>well-being</measure>
    <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.</time_frame>
    <description>The test will be performed at the admission for the rehabilitation unit and at discharged.&#xD;
Well-being and fatigue is according to WHO-5 well-being scale, Multidimensional Fatigue Inventory-20 (MFI-20), Visual Analog Scala for fatigue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <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.</time_frame>
    <description>The test will be performed at the admission for the rehabilitation unit and at discharged.&#xD;
Mild, moderate or severe depression according to Hamilton-D6 (HAM-D6), Major Depression Inventory (MDI) or Hospital Anxiety and Depression Scale (HADS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <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.</time_frame>
    <description>The test will be performed at the admission for the rehabilitation unit and at discharged.&#xD;
Anxiety according to HADS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian rhythm specific blood marker</measure>
    <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.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep and sleep-wake cycle</measure>
    <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.</time_frame>
    <description>The test will be performed at the admission for the rehabilitation unit and at discharged.&#xD;
Sleep will be measured according to Polysomnography, Actigraph, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <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.</time_frame>
    <description>The test will be performed at the admission for the rehabilitation unit and at discharged.&#xD;
Level of cognitive function is according to Montreal Cognitive Assessment (MoCA), Trail Marking Test (TMT), and Confusion Assessment Method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic function</measure>
    <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.</time_frame>
    <description>The test will be performed at the admission for the rehabilitation unit and at discharged.&#xD;
autonomic dysfunction will be measured according to Polysomnography by heart rate and blod pressure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical status</measure>
    <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.</time_frame>
    <description>The test will be performed at the admission for the rehabilitation unit and at discharged.&#xD;
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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Stroke classification</measure>
    <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.</time_frame>
    <description>Stroke classification according to TOAST criteria and Oxfordshire criteria.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ophthalmological status</measure>
    <time_frame>during hospitalization in the rehabilitation unit.</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>cause of death after stroke</measure>
    <time_frame>assessed at follow-up during admission</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Stroke</condition>
  <condition>Sleep Apnea Syndromes</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Control department</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control department where the conventional light is installed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Circadian Light luminaries</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Circadian Light luminaries</intervention_name>
    <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.</description>
    <arm_group_label>Circadian Light luminaries</arm_group_label>
    <other_name>Chroma Viso</other_name>
    <other_name>Ergonomic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients evaluated as candidates to the rehabilitation units from May 1th 2014 to May&#xD;
             1th 2015.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) &lt; 15&#xD;
&#xD;
          -  No functioning of the optic nerve or retina in both eyes&#xD;
&#xD;
          -  Unable to open both eyes&#xD;
&#xD;
          -  Non communicating patients e.g. aphasia (incompetent patients)&#xD;
&#xD;
          -  Unable to cooperate to the physical examinations&#xD;
&#xD;
          -  Less than 2 weeks of hospitalization in the rehabilitation department&#xD;
&#xD;
          -  If the sub investigator finds the study participant unfit to conduct the&#xD;
             investigations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helle K Iversen, MD, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Poul Jennum, MD, DMSc</last_name>
    <role>Study Director</role>
    <affiliation>Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anders S West, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>June 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>December 20, 2017</last_update_submitted>
  <last_update_submitted_qc>December 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glostrup University Hospital, Copenhagen</investigator_affiliation>
    <investigator_full_name>Helle Klingenberg Iversen, MD, DmSc</investigator_full_name>
    <investigator_title>MD, DMSc</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Stroke</keyword>
  <keyword>Cerebral Infarction</keyword>
  <keyword>Sleep disorders</keyword>
  <keyword>Circadian Rhythm disorders</keyword>
  <keyword>Circadian Light</keyword>
  <keyword>Light therapy</keyword>
  <keyword>Melatonin</keyword>
  <keyword>Sleep</keyword>
  <keyword>Sleep apnea</keyword>
  <keyword>Coagulation disturbances</keyword>
  <keyword>Bone metabolism</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Mood disorders</keyword>
  <keyword>Mental disorders</keyword>
  <keyword>Neurologic Manifestations</keyword>
  <keyword>Signs and Symptoms Cerebrovascular Disorders</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Vascular Disease</keyword>
  <keyword>Brain Infarction</keyword>
  <keyword>Brain Ischemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02186392
org study id: H-4-2013-114
nct id: NCT02186392
lead sponsor: 
has dmc: No
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:

        -  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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: well-being
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.
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.
measure: Depression
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.
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).
measure: Anxiety
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.
description: The test will be performed at the admission for the rehabilitation unit and at discharged.
Anxiety according to HADS.
measure: 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.
measure: Sleep and sleep-wake cycle
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.
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.
measure: Cognitive function
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.
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.
measure: Autonomic function
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.
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.
measure: Physical status
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.
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).
measure: Stroke classification
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.
description: Stroke classification according to TOAST criteria and Oxfordshire criteria.
measure: Ophthalmological status
time frame: during hospitalization in the rehabilitation unit.
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.
measure: cause of death after stroke
time frame: assessed at follow-up during admission
arm group label: Control department
arm group type: No Intervention
description: The control department where the conventional light is installed.
arm group label: Circadian Light luminaries
arm group type: Experimental
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: Circadian Light luminaries
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.
arm group label: Circadian Light luminaries
other name: Chroma Viso
other name: Ergonomic
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Helle K Iversen, MD, DMSc
role: Study Chair
affiliation: Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
last name: Poul Jennum, MD, DMSc
role: Study Director
affiliation: Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital.
last name: Anders S West, MD
role: Principal Investigator
affiliation: Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Glostrup University Hospital, Copenhagen
investigator full name: Helle Klingenberg Iversen, MD, DmSc
investigator title: MD, DMSc
mesh term: Sleep Apnea Syndromes
mesh term: Stroke
mesh term: Depression