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

Glostrup University Hospital, Copenhagen

Status: Completed

Conditions: Sleep Apnea Syndromes; Stroke; Depression; Anxiety

Treatments: Device: Circadian Light luminaries

Study type: Interventional

Funder types: Other

Identifiers

NCT02186392

H-4-2013-114

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

Control department

No Intervention group

Description:

The control department where the conventional light is installed.

Circadian Light luminaries

Experimental group

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.

Treatment:

Device: Circadian Light luminaries