Actively Recruiting
Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention
Led by Charite University, Berlin, Germany · Updated on 2026-01-23
40
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators will examine the effects of dynamic light therapy on circadian rhythms in delirious intensive care unit (ICU) patients. In a randomized controlled trial (RCT), they will investigate the effects of a specific light algorithm on rhythms of serum melatonin, clock gene expression, the proteome, and metabolome, compared to standard hospital lighting, supported by the data science algorithms to improve vital-based algorithms with light interventions.
CONDITIONS
Official Title
Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient capable of giving consent or has a legal caregiver/authorized representative if unable to consent
- Male or female patients aged 18 years or older
- Expected intensive care unit stay of 2 days or more
- Positive delirium diagnosis during and up to 30 days after study inclusion (determined by CAM-ICU, at least once per shift)
You will not qualify if you...
- Participation in other clinical studies during the study period and 10 days before
- Previous ICU treatment during the current hospital stay
- Patients with psychiatric diseases
- History of stroke with severe residual cognitive deficits
- History of cardiopulmonary arrest or pulseless electric activity with resuscitation followed by therapeutic hypothermia during entire hospital stay
- Amaurosis
- History of sleep-related breathing disorders
- History or suspicion of hypoxic brain damage
- History or suspicion of elevated intracranial pressure in the 7 days before study inclusion
- Patient refuses participation in any clinical trial via power of attorney or provision
- Inability to obtain informed consent in time
- History of photoallergic reactions or visually triggered seizures
- Severe eye diseases such as retinopathy or glaucoma, or high sensitivity to bright light
- Patients with liver cirrhosis
- Patients with expected survival less than 24 hours
- Optic neuritis within the last 3 months
- Travel across two time zones within 3 months before screening
- Women who are pregnant, breastfeeding, have a positive pregnancy test, or plan to become pregnant during the trial
- Therapy-refractory blood coagulation disorder and inability to consent are exclusion criteria for muscle biopsy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte
Berlin, Germany, 10117
Actively Recruiting
2
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum
Berlin, Germany, 13353
Actively Recruiting
Research Team
C
Claudia Spies, MD, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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