RecruitingNot ApplicableNCT05807178

Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention


Sponsor

Charite University, Berlin, Germany

Enrollment

40 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria18

  • 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

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Interventions

DEVICEDynamic Light Therapy Device, LSA-1

Dynamic Light Therapy

DEVICEDynamic Light Therapy Device, LSA-2

Light Exposition


Locations(2)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte

Berlin, Germany

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum

Berlin, Germany

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NCT05807178


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