HEaling LIght Algorithms for the ICU Patient

NCT05556811 | Completed

• 1 other identifier: 20018170
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective, randomized controlled trial is to investigate if mechanically ventilated patients who are treated with a Light Scheduling Algorithm with high circadian effective irradiances are better able to preserve and induce physiological melatonin rhythms compared to patients who are treated with an application of lower irradiances. The investigators will further evaluate the impact on delirium prevalence, stress level and general outcome parameters.

Conditions

Critical Care; Phototherapy

Keywords

Light therapy; Melatonin; Critical Care; Delirium

Outcome Measures

Primary Outcomes (1)

• Change in serum melatonin concentration

  Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations

  Plasma melatonin levels will be assessed for a maximum of five 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. (6am, 10am, 2pm, 6pm, 10pm, 2am, 6am).

Secondary Outcomes (14)

• Prevalence of intensive care unit delirium

  Participants will be followed up to 6 days after intensive care unit admission

• Delirium Severity

  Participants will be followed up to 6 days after intensive care unit admission

• Depth of Sedation

  Participants will be followed up to 6 days after intensive care unit admission

• Severity of Pain

  Participants will be followed up to 6 days after intensive care unit admission

• Patient comfort

  Participants will be followed up to 6 days after intensive care unit admission

Study Arms (3)

LSA-1

ACTIVE COMPARATOR

Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances + Blue Enriched Light episodes

Device: Dynamic Light Therapy Device, LSA-1

LSA-2

ACTIVE COMPARATOR

Light Scheduling Algorithm-2 (LSA-2): High circadian effective irradiances without Blue Enriched Light episodes.

Device: Dynamic Light Therapy Device, LSA-2

LSA-3

ACTIVE COMPARATOR

Light Scheduling Algorithm-3 (LSA-3): Irradiance levels comparable to conventional hospital lighting (control group).

Device: Dynamic Light Therapy Device, LSA, 3

Interventions

Dynamic Light Therapy Device, LSA-1 DEVICE

Dynamic Light Therapy

LSA-1

Dynamic Light Therapy Device, LSA-2 DEVICE

Dynamic Light Therapy

LSA-2

Dynamic Light Therapy Device, LSA, 3 DEVICE

Dynamic Light Therapy

LSA-3

Eligibility Criteria

• Age: 18 Years - 110 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/authorized 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 ≥ 5 days
• Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure \> 6 hours/day or high flow \>30 liters) on the day of ICU admission

You may not qualify if:

• Participation in other clinical studies during the study period and ten days before
• 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
• Analphabetism
• Anacusis or Hypoacusis with hearing aid device, Amaurosis
• Lacking willingness to save and hand out data within the study
• Accommodation in an institution due to an official or judicial order
• History of sleep-related breathing disorders
• History or suspicion of hypoxic brain damage
• Patients with an open chest after cardiac surgery
• 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
• Severe eye diseases
• History of photoallergic reactions

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Links

• Website of Research Group
• Website of Department

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: September 27, 2022
• Study Start: September 1, 2022
• Primary Completion: January 15, 2024
• Study Completion: May 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)