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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186392
• Other study ID #: H-4-2013-114
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: December 20, 2017
• Start date: May 2014
• Est. completion date: August 15, 2016

Study information

• Verified date: December 2017
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 15, 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Sleep Apnea Syndromes
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Denmark	Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical status	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).	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	Stroke classification	Stroke classification according to TOAST criteria and Oxfordshire criteria.	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	Ophthalmological status	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.	during hospitalization in the rehabilitation unit.
Other	cause of death after stroke		assessed at follow-up during admission
Primary	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.	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.
Primary	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).	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.
Primary	Anxiety	The test will be performed at the admission for the rehabilitation unit and at discharged.; Anxiety according to HADS.	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.
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.
Primary	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.	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	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.	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	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.	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.