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Completed

NCT Number: NCT02186392

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Chroma Viso, Ergonomic

Primary outcomes

  1. 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.

    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.

  2. 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.

    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).

  3. 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.

    The test will be performed at the admission for the rehabilitation unit and at discharged.

    Anxiety according to HADS.

  4. 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.

  5. 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.

    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 outcomes

  1. 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.

    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.

  2. 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.

    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.

Other outcomes

  1. 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.

    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).

  2. 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.

    Stroke classification according to TOAST criteria and Oxfordshire criteria.

  3. Ophthalmological status

    Time frame: during hospitalization in the rehabilitation unit.

    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.

  4. cause of death after stroke

    Time frame: assessed at follow-up during admission

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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