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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSA-1 | Experimental | Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances |
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| LSA-2 | Active Comparator | Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Light Therapy Device, LSA-1 | Device | Dynamic Light Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clock genes | Prevalence of physiological circadian rhythmicity measured by expression activity of clock genes. | Clock gene expression levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion. |
| Metabolomics |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian analyzes of routine high-output clinical data (Working package 1) | Relevant clinical data (routine and study data), which are associated with circadian rhythmicity | Before the start of this investigation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Spies, MD, Prof. | Contact | +49 30 450 55 11 02 | claudia.spies@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte | Recruiting | Berlin | 10117 | Germany |
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Evaluation of Specific Light Algorithms (Dynamic Lightening Schedule Therapy Devices) to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients
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| Dynamic Light Therapy Device, LSA-2 |
| Device |
Light Exposition |
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Prevalence of physiological circadian rhythmicity measured by metabolomic concentrations.
| Metabolomic measurements be assessed up to 3 (6-9) months. |
| Proteomics | Prevalence of physiological circadian rhythmicity measured by proteomic concentrations. | Proteomic measurements will be assessed up to 3 (6-9) months. |
| Inflammation parameters | Prevalence of physiological circadian rhythmicity measured by inflammation parameters (cytokines, chemokines, extracellular mitochondria concentrations. | Inflammation parameter levels will be assessed up to 3 (6-9) months. |
| Incidence of intensive care unit delirium | Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU), Binary scale (Positive/Negative) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Delirium-free days in the intensive care unit | Delirium-free days will be measured in day without positive delirium scoring (Confusion Assessment Method for the intensive care unit (CAM-ICU), Binary scale (Negative)) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Delirium Severity | Delirium severity will be measured with the Intensive Care Delirium Screening Checklist (ICDSC). The higher the score the worse - higher score = higher delirium severity(ICDSC) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Depth of Sedation | Level of sedation will be measured with the Richmond Agitation-Sedation-Scale (RASS), -5 to +4, negative scores translates to a higher degree of sedation. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Level of analgesia 1 | Severity of pain will be measured with the Numeric Rating Scale (NRS). A higher score corresponds to a higher severity of pain.Score values from 0 to 10. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Level of analgesia 2 | Severity of pain will be measured with the Visualized Numeric Rating Scale (NRS-V). A higher score corresponds to a higher severity of pain.Score values from 0 to 10. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Level of analgesia 3 | Severity of pain will be measured with the Faces Pain Scale-Revised (FPS-R). A higher score corresponds to a higher severity of pain.Score values from 0 to 10. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Level of analgesia 4 | Severity of pain will be measured with the Behavioral Pain Scale (BPS) . A higher score corresponds to a higher severity of pain.Score values from 3 to 12. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Level of analgesia 5 | Severity of pain will be measured with the Behavioral Pain Scale for Non- Intubated (BPS-NI). A higher score corresponds to a higher severity of pain. A higher score corresponds to a higher severity of pain.Score values from 3 to 12. A higher score means worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Total amount of opioids | Total amount of opioids administered per ICU treatment day will be measured in with morphine equivalents for each administered opioids. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Total amount of sedatives | Total amount of sedatives administered per ICU treatment day by dose summation for each sedative. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Duration of ventilation | Duration of invasive and non-invasive ventilation in hours | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| ICU length of stay | ICU length of stay will be measured in days | Participants will be followed up until ICU discharge, an expected average of 3 days. |
| Hospital length of stay | Hospital length of stay will be measured in days | Participants will be followed up until hospital dischargean expected average of 7 days. |
| Sepsis | Does patient fulfil sepsis criteria (Yes/No) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Septic shock | Does patient fulfil criteria for septic shock (Yes/No) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Sequential Organ Failure Assessment (SOFA-Score) | Predicts ICU mortality based on lab results and clinical data. . Score values between 0 and max. 24. Higher scores mean worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Simplified Acute Physiology Score (SAPS II) | Estimates mortality in ICU patients, comparable to APACHE II.Score values between 0 and max. 163. Higher scores mean worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Therapeutic Intervention Scoring System (TISS-28) | The Simplified Therapeutic Intervention Scoring System TISS-28 consists of 28 items. It is intended to accurately measure the level of care required for a patient in the Intensive Care Unit (ICU). Score values between 0 and max. 78. Higher scores mean higher level of required care for ICU patients. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II) | The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States.. Score values between 0 and max. 71. Higher scores mean worse outcome. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Medical Research Council (MRC) Score | The muscle scale grades muscle power on a scale of 0 to 5 (5= Muscle contracts normally against full resistance.; 0 = No movement is observed). | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Hand strength measurements | Hand grip strength is measured with a dynometer. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Intensive Care Mobility Scale | To record the patient's highest level of mobility in the Intensive Care Unit. Scale from 0 to 10. 0 meaning no movement and 10 mean walking independently. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| FIM Score (Functional Independence Measure) | FIM™ is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Mean blood glucose (mg/dl) | Plasma glucose (PG) levels are determined by taking a blood sample from participants. It can be measured in mg/dL. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Blood glucose variability (SD in mg/dl) | Blood glucose variability (SD in mg/dl) represents how much glucose levels fluctuate over time from a given average. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Percentage of time in target glucose range (%) | Blood glucose levels outside the ranges listed in the blood sugar levels chart by age above are categorized as either high or low blood sugar. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Insulin requirement (IU/kg/h) | The amount of insuline is measured in units (IU). | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Post Intensive Care Syndrome (PICS) | Binary scale (Positive/Negative). Diagnosis of "PICS" is defined by a new impairment or worsening of the health condition after intensive care unit stay and a clinically significant distress in at least one of the following outcome measurement instruments: Patient Health Questionnaires (PHQ-9, PHQ-8, PHQ-4), Generalized Anxiety Disorder Scales (GAD-2 and GAD-7), Impact of Event Scale Revised (IES-R), MiniCog, Animal Naming Test, Trail Making Test (TMT-A, TMT-B), Repeatable Battery for the Assessment of Neuropsychological Satus (RBANS), Timed Up-and-Go (TUG), Handgrip Strength, EQ-5D-5L, subjective assessment NRS, WHO Disability Assessment Schedule (WHODAS), Short Physical Performance Battery (SPPB). | Up to 3 (6-9) months |
| Analysis of the sleep architecture measured by polysomnography 1 | Binary scale (Positive/Negative). All participants will be undergoing a polysomnography in the St. Hedwig hospital. | Up to 3 (6-9) months |
| Analysis of the sleep architecture measured by polysomnography 2 | All participants will be undergoing a polysomnography one night in the Intensive Care Unit. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| MCTQ (Munich Chronotype Questionnaire) | In this questionnaire, the typical sleep behaviour over the past 4 week will be reported | Up to 3 (6-9) months |
| Actigraphy | Aktigraphy is measured by ActLumus in a time period of six weeks. | Up to 3 (6-9) months |
| Sleep diary | Sleep parameter are documented by a sleep diary in a time period of six weeks. | Up to 3 (6-9) months |
| Molecular data | Molecular data from muscle needle biopsies in the morning and evening on a study day | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Physiotherapy | Physiotherapy is measured by a questionnaire. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Nutritional Therapy | Nutritional Therapy is measured by chart review. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Nutritional Therapy Complications | Nutritional Therapy Complications are measured by chart review. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Target protein intake | Rate in patient days on which the target protein intake was achieved | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Adherence to the diet plan | Rate of days with adherence to the diet plan (yes/no) | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Composition of the administered food | Composition of the administered food is measured by macro- and micronutrients according to documentation | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Daily feeding breaks | Daily feeding breaks are measured in hours | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Wheather data | Weather data are extracted from German Wheather Administration and Federal Environment Agency. | Participants will be followed up until discharge from the intensive care unit (maximum up to day 5) |
| Cognition 1 | Cognition 1 is measured by MiniCog | Up to 3 (6-9) months |
| Cognition 2 | Cognition 2 is measured by Animal Naming Test | Up to 6 months |
| Cognition 3 | Cognition 3 is measured by Trail Making Tests A&B | Up to 3 (6-9) months |
| Mental impairments | Mental impairments are measured using the PHQ-4. The PHQ-4 (Patient Health Questionnaire-4) is a brief, 4-item self-report tool screening for anxiety and depression symptoms, combining the PHQ-2 (depression) and GAD-2 (anxiety) scales, with scores from 0-12 indicating increasing symptom severity (Normal: 0-2, Mild: 3-5, Moderate: 6-8, Severe: 9-12). Each item asks how often in the last two weeks you've been bothered by something, with responses 0 (not at all) to 3 (nearly every day), and scores ≥3 on the first two items suggest depression, while ≥3 on the last two suggest anxiety, warranting further clinical assessment. | Up to 3 (6-9) months |
| Quality of life 1 | Quality of life 1 is measured by EQ-5D-5L. The EQ-5D-5L is a widely used patient-reported outcome (PRO) tool measuring health-related quality of life with five dimensions (Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression), each having five severity levels (no to extreme problems) An EQ-5D-5L result describes health status in 5 dimensions on a 5-point scale (none to extreme problems) and is summarized into a single index value (usually 0 to 1), with 1 representing perfect health, supplemented by a visual analog scale (EQ VAS) value for self-assessment of health. | Up to 3 (6-9) months |
| Quality of life 2 | Quality of life 2 is measured by WHODAS 2.0. The WHODAS (World Health Organization Disability Assessment Schedule) 2.0 12-item version is a standardized, cross-cultural tool measuring health and disability by assessing difficulties in six core domains (cognition, mobility, self-care, getting along, life activities, participation) over the past 30 days, and contains 2 questions per domain. WHODAS 2.0 uses a 1-5 Likert scale (none to extreme difficulty) for its items, with scores summed and converted to a 0-100 standardized score (higher is worse), offering simple addition for general scoring or complex Item Response Theory (IRT) for weighted domain scores, with a threshold of >10 (12-item) indicating top 10% disability, all to assess disability across six domains. | Up to 3 (6-9) months |
| Mortality | Mortality is measured by statistical data. | Up to 6 months |
| Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum | Recruiting | Berlin | 13353 | Germany |
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