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Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Circadian Dysrhythmia

NCT05807178

Charite University, Berlin, Germany

31 January 2026

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