Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

NCT ID: NCT05807178

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LSA-1

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

Group Type: EXPERIMENTAL

Dynamic Light Therapy Device, LSA-1

Intervention Type: DEVICE

Dynamic Light Therapy

LSA-2

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

Group Type: ACTIVE_COMPARATOR

Dynamic Light Therapy Device, LSA-2

Intervention Type: DEVICE

Light Exposition

Interventions

Dynamic Light Therapy Device, LSA-1

Dynamic Light Therapy

Intervention Type: DEVICE

Dynamic Light Therapy Device, LSA-2

Light Exposition

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Site Status: RECRUITING

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

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Spies, MD, Prof.

Role: CONTACT

claudia.spies@charite.de

+49 30 450 55 11 02

Facility Contacts

Claudia Spies, MD, Prof.

Role: primary

Claudia Spies, MD, Prof.

Role: primary

Other Identifiers

CIRCA-MED-WP2

Identifier Type: -

Identifier Source: org_study_id