Clinical trial NCT02186392: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: well-being
timeFrame: 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: Depression
timeFrame: 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: Anxiety
timeFrame: 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: Circadian rhythm specific blood marker
timeFrame: 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
timeFrame: 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 outcomes:
measure: Cognitive function
timeFrame: 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: Autonomic function
timeFrame: 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 outcomes:
measure: Physical status
timeFrame: 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: Stroke classification
timeFrame: 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: Ophthalmological status
timeFrame: during hospitalization in the rehabilitation unit.
measure: cause of death after stroke
timeFrame: assessed at follow-up during admission
Locations:
city: Glostrup
country: Denmark
facility: Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
Study officials:
affiliation: Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
name: Helle K Iversen, MD, DMSc
role: STUDY_CHAIR
affiliation: Department Director of Danish Center for Sleep Medicine, Neurophysiological Department, Glostrup Hospital.
name: Poul Jennum, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Department of clinical stroke reseach, Department of Neurology, Glostrup Hospital.
name: Anders S West, MD
role: PRINCIPAL_INVESTIGATOR
References: