Clinical trial NCT05807178: Enhancement of Circadian Rhythms in ICU Patients Through Light Intervention
Official title: Enhancement of Circadian Rhythms in ICU Patients Through Light Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Circadian Dysrhythmia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation of Specific Light Algorithms (Dynamic Light Therapy Devices, LSA-1 and LSA-2) to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients
Primary purpose: TREATMENT

Brief summary: The investigators will examine the effects of dynamic light therapy on circadian rhythms in 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: 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

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
* Analphabetism
* Anacusis or Hypoacusis with hearing aid device,
* Amaurosis
* Accommodation in an institution due to an official or judicial order
* 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
* 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
* 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

Primary outcomes:
measure: Rhythmicity of melatonin concentration
timeFrame: Plasma melatonin levels will be assessed for a maximum of five 24-hour periods.
Secondary outcomes:
measure: Clock genes
timeFrame: Clock gene expression levels will be assessed for a maximum of five 24-hour periods.
measure: Metabolomics
timeFrame: Metabolomic measurements be assessed for a maximum of five 24-hour periods.
measure: Proteomics
timeFrame: Proteomic measurements will be assessed for a maximum of five 24-hour periods.
measure: Inflammation parameters
timeFrame: Inflammation parameter levels will be assessed for a maximum of five 24-hour periods.
measure: Incidence of intensive care unit delirium
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Delirium-free days in the intensive care unit
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Delirium Severity
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Depth of Sedation
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Level of analgesia 1
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Level of analgesia 2
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Level of analgesia 3
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Level of analgesia 4
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Level of analgesia 5
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Total amount of opioids
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Total amount of sedatives
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Duration of ventilation
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: ICU length of stay
timeFrame: Participants will be followed up until ICU discharge, an expected average of 3 days.
measure: Hospital length of stay
timeFrame: Participants will be followed up until hospital dischargean expected average of 7 days.
measure: Sepsis
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Septic shock
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Sequential Organ Failure Assessment (SOFA-Score)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Simplified Acute Physiology Score (SAPS II)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Therapeutic Intervention Scoring System (TISS-28)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Medical Research Council (MRC) Score
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Hand strength measurements
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Intensive Care Mobility Scale
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: FIM Score (Functional Independence Measure)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Mean blood glucose (mg/dl)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Blood glucose variability (SD in mg/dl)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Percentage of time in target glucose range (%)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Insulin requirement (IU/kg/h)
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: Post Intensive Care Syndrome (PICS)
timeFrame: Up to 6 months
measure: Analysis of the sleep architecture measured by polysomnography 1
timeFrame: Up to 6 months
measure: Analysis of the sleep architecture measured by polysomnography 2
timeFrame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
measure: MCTQ (Munich Chronotype Questionnaire)
timeFrame: Up to 6 months
measure: Actigraphy
timeFrame: Up to 6 months
measure: Sleep diary
timeFrame: Up to 6 months
Other outcomes:
measure: Circadian analyzes of routine high-output clinical data (Working package P1)
timeFrame: Before the start of this investigation
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: