Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

Charité University Medicine Berlin

Status: Enrolling

Conditions: Circadian Dysrhythmia

Treatments: Device: Dynamic Light Therapy Device, LSA-1; Device: Dynamic Light Therapy Device, LSA-2

Study type: Interventional

Funder types: Other

Identifiers

NCT05807178

CIRCA-MED-WP2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

LSA-1

Experimental group

Description:

Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances

Treatment:

Device: Dynamic Light Therapy Device, LSA-1

LSA-2

Active Comparator group

Description:

Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group).

Treatment:

Device: Dynamic Light Therapy Device, LSA-2