The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation.

NCT06922409 | Recruiting

• 1 other identifier: H-22014644
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Light is the most important regulator of circadian rhythm. Naturalistic light, which contains the spectrum of sunlight throughout the day, has been shown to have a positive impact on mental states such as depression and fatigue in stroke and other diseases requiring long-term hospitalization. Depression and fatigue are very common complications after stroke, with a frequency of 30% and 85%, respectively. Both are significantly related to reduced quality of life and early death. Both the causes and pathophysiology behind these complications are unknown, but it is assumed that disturbances (inflammation and cell death) in brain areas and brain networks related to arousal, sleep, circadian rhythm, and the frontal lobe play a role. The hypothesis is that it is possible to detect changes in brain networks related to depression and fatigue by MRI, and that naturalistic light will affect these changes. Method: Stroke patients requiring a minimum of 10 days of rehabilitation are transferred to a neurorehabilitation unit with naturalistic lighting. Examination: Validated tests for fatigue, depression, sleep and cognitive functions. Pathophysiological studies:

• MRI focusing on cerebral blood flow, metabolism, and cerebral networks.
• Spinal fluid analyses for hormones and markers involved in immunological response as well as wakefulness/arousal and depression.
• Sleep assessments.

Conditions

Post Stroke Depression; Post Stroke Fatigue; Circadian Dysregulation; Stroke

Keywords

circadian rhythm disruption; Stroke; Post Stroke Depression; Post Stroke Fatigue; Light therapy; Circadian Light

Outcome Measures

Primary Outcomes (1)

• Fatigue and depression

  Primary hypothesis: Naturalistic light reduce the major depression inventory questionnaire score and multidimensional fatigue inventory questionnaire score from baseline til discharge. Mood-related network will too show positive changes measured by whole brain resting-state connectivity in post-stroke patients compared with a control group without fatigue and depression.

  From admission at the rehabilitation unit to the time of discharge aprox. 10 days.

Secondary Outcomes (4)

• Cognitive function

  From admission to the neurorehabilitation unit to the time of discharge aprox 10 days..

• Sleep quality

  From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..

• Hypocretin

  From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days..

• CFS inflammation

  From admission to the neurorehabilitation unit to the time of discharge aprox. 10 days.

Study Arms (2)

Moderate-severe depression or/and fatigue

ACTIVE COMPARATOR

Naturalistic Light Intervention

Device: Naturalistic Light Intervention

No measured depression or/and fatigue

ACTIVE COMPARATOR

Naturalistic Light Intervention

Device: Naturalistic Light Intervention

Interventions

Naturalistic Light Intervention DEVICE

Naturalistic light as an Intervention A 24-hour naturalistic lighting scheme is implemented in all areas and rooms in the unit at Rigshospitalet Glostrup with a computer-controlled lighting scheme (ChromaViso, Denmark). The naturalistic lighting scheme is constantly running. The lighting imitate the sunlight rhythm following the principles of Lucas et al.

Also known as: Circadiain Light Intervention, Dynamic Light Intervention

Moderate-severe depression or/and fatigue; No measured depression or/and fatigue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scoring moderate-severe fatigue and/or depression OR NO fatigue and/or depressione which are evaluated as candidates for the rehabilitation unit.

You may not qualify if:

• GCS \< 15
• No functioning nervus opticus or retina in both eyes
• Unable to open both eyes
• Non communicating patients e.g. severe aphasia (incompetent patients)
• Unable to cooperate to the physical examinations
• Less than 10 days of hospitalization in the rehabilitation department
• Claustrophobia
• If the sub investigator finds the study participant unfit to conduct the investigations

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Chromaviso A/S: collaborator

Study Sites (1)

Faculty of Health and Medical Sciences - University of Copenhagen

Glostrup Municipality, Capital Region, 2600, Denmark

RECRUITING

Related Publications (1)

• West A, Jennum P, Simonsen SA, Sander B, Pavlova M, Iversen HK. Impact of naturalistic lighting on hospitalized stroke patients in a rehabilitation unit: Design and measurement. Chronobiol Int. 2017;34(6):687-697. doi: 10.1080/07420528.2017.1314300. Epub 2017 Apr 21.

  PMID: 28430522 BACKGROUND

MeSH Terms

Conditions

Chronobiology Disorders; Stroke

Condition Hierarchy (Ancestors)

Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anders Sode West, MD, PhD

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Sode West, MD, PhD.

CONTACT

+4538634051; anders.sode.west@regionh.dk

Helle Iversen, MD, D.M.Sc

CONTACT

+4538634051; helle.klingenberg.iversen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D. Principal Investigator

Model Details: Study Design: Case-control study Study description: Patients admitted at the acute stroke unit will be screened for fatigue and depression. The patients will be selected for the study by the present and absent of moderate-severe depression and fatigue (50%+50%). The control group will be patients without any symptoms of depression and fatigue. The intervention group will be patients scored to have moderate-severe depression and fatigue. All patients must be selected to neurorehabilitation for a minimum of 10 days where the intervention (naturalistic light) is installed.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 10, 2025
• Study Start: April 10, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

DK (1)