Stabilizing circadian rhythms in delirious ICU patients with timed dynamic light

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized controlled design, adults with delirium in the ICU will receive a specific dynamic light algorithm delivered by LSA devices or standard hospital lighting. The team will measure rhythms of serum melatonin, clock gene expression, and broad proteomic and metabolomic profiles to determine biologic entrainment effects. Data science algorithms will be used to link light interventions with vital-sign based algorithms and to analyze multi-omic time-series changes. Enrollment occurs at Charité campuses and targets patients expected to remain in the ICU at least 48 hours with CAM-ICU–documented delirium.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Claudia Spies, MD, Prof.
• Email: claudia.spies@charite.de
• Phone: +49 30 450 55 11 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.