Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

NCT05807178 | Recruiting

• 1 other identifier: CIRCA-MED-WP2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Circadian Dysrhythmia

Outcome Measures

Primary Outcomes (1)

• Rhythmicity of melatonin concentration

  Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.

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

Secondary Outcomes (54)

• Clock genes

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

• Metabolomics

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

• Proteomics

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

• Inflammation parameters

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

• Incidence of intensive care unit delirium

  Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)

Other Outcomes (1)

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

  Before the start of this investigation

Study Arms (2)

LSA-1

EXPERIMENTAL

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

Device: Dynamic Light Therapy Device, LSA-1

LSA-2

ACTIVE COMPARATOR

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

Device: Dynamic Light Therapy Device, LSA-2

Interventions

Dynamic Light Therapy Device, LSA-1 DEVICE

Dynamic Light Therapy

LSA-1

Dynamic Light Therapy Device, LSA-2 DEVICE

Light Exposition

LSA-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

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

Berlin, 10117, Germany

RECRUITING

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

Berlin, 13353, Germany

RECRUITING

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 55 11 02; claudia.spies@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Model Details: Evaluation of Specific Light Algorithms (Dynamic Lightening Schedule Therapy Devices) to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 11, 2023
• Study Start: January 20, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)