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Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

ConditionCircadian Dysrhythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dynamic Light Therapy Device, LSA-1

    Device

    Dynamic Light Therapy

  • Dynamic Light Therapy Device, LSA-2

    Device

    Light Exposition

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: LSA-1Experimental treatment 1 intervention
Group B: LSA-2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rhythmicity of melatonin concentration

Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.

Time frame
Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion

Secondary outcomes

1

Clock genes

Prevalence of physiological circadian rhythmicity measured by expression activity of clock genes.

Time frame
Clock gene expression levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion.
2

Metabolomics

Prevalence of physiological circadian rhythmicity measured by metabolomic concentrations.

Time frame
Metabolomic measurements be assessed up to 3 (6-9) months.
3

Proteomics

Prevalence of physiological circadian rhythmicity measured by proteomic concentrations.

Time frame
Proteomic measurements will be assessed up to 3 (6-9) months.
4

Inflammation parameters

Prevalence of physiological circadian rhythmicity measured by inflammation parameters (cytokines, chemokines, extracellular mitochondria concentrations.

Time frame
Inflammation parameter levels will be assessed up to 3 (6-9) months.

Other outcomes

1

Circadian analyzes of routine high-output clinical data (Working package 1)

Relevant clinical data (routine and study data), which are associated with circadian rhythmicity

Time frame
Before the start of this investigation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charite University, Berlin, Germany

Lead sponsor

Source ClinicalTrials.gov
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