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Clinical Trials in Germany / NCT05807178
Recruiting Not applicable

Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

NCT05807178 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2026-01-20
Last updated
2026-01-23

Condition(s) studied

Circadian Dysrhythmia

Investigational drug(s) / intervention(s)

Dynamic Light Therapy Device, LSA-1Dynamic Light Therapy Device, LSA-2

Dynamic Light Therapy Device, LSA-1: Dynamic Light Therapy

Dynamic Light Therapy Device, LSA-2: Light Exposition

Study summary

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)

Trial sites (2)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT05807178 on ClinicalTrials.gov ↗ ← All trials in Germany