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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit
* Male and female patients with age ≥ 18 years
* Expected intensive care unit stay ≥ 2 days
* Positive delirium during and up to a maximum of 30 days after study inclusion (determined by CAM-ICU, at least once per shift)
Exclusion Criteria:
* Participation in other clinical studies during the study period and ten days before
* Previous ICU treatment during the current hospital stay
* Patients with psychiatric diseases
* Patients with a history of stroke and known severe residual cognitive deficits
* Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary 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 last 7 days before study inclusion
* Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
* The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time
* History of photoallergic reactions or history of visually triggered seizures
* Severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light
* Patients with liver cirrhosis
* Patients with a probability of survival \<24h
* Optic neuritis within the last 3 months
* Travel across two time zones within 3 months prior to study screening
* Women who are pregnant, have a positive pregnancy test, are breastfeeding or plan to become pregnant during the course of this clinical trial
* Therapy-refractory blood coagulation disorder and inability to consent are exclusion criteria for a muscle biopsy
Primary outcome measure(s)
Rhythmicity of melatonin concentration — Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.
Trial sites (2)
Facility
City
Region
Status
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte
Berlin
Germany
Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum
Berlin
Germany
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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