An interventional study of Dynamic Light Therapy Device, LSA-1 and Dynamic Light Therapy Device, LSA-2 in Circadian Dysrhythmia, sponsored by Charite University, Berlin, Germany. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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.
Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances
Device: Dynamic Light Therapy Device, LSA-1
Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group).
Device: Dynamic Light Therapy Device, LSA-2
Dynamic Light Therapy
Light Exposition
Rhythmicity of melatonin concentration
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.
Time frame: Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion
Clock genes
Prevalence of physiological circadian rhythmicity measured by expression activity of clock genes.
Time frame: Clock gene expression levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion.
Metabolomics
Prevalence of physiological circadian rhythmicity measured by metabolomic concentrations.
Time frame: Metabolomic measurements be assessed up to 3 (6-9) months.
Proteomics
Prevalence of physiological circadian rhythmicity measured by proteomic concentrations.
Time frame: 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.
Time frame: 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)
Time frame: 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))
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Participants will be followed up until hospital dischargean expected average of 7 days.
Sepsis
Does patient fulfil sepsis criteria (Yes/No)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 3 (6-9) months
Actigraphy
Aktigraphy is measured by ActLumus in a time period of six weeks.
Time frame: Up to 3 (6-9) months
Sleep diary
Sleep parameter are documented by a sleep diary in a time period of six weeks.
Time frame: Up to 3 (6-9) months
Molecular data
Molecular data from muscle needle biopsies in the morning and evening on a study day
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Physiotherapy
Physiotherapy is measured by a questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Up to 3 (6-9) months
Cognition 2
Cognition 2 is measured by Animal Naming Test
Time frame: Up to 6 months
Cognition 3
Cognition 3 is measured by Trail Making Tests A\&B
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 (6-9) months
Mortality
Mortality is measured by statistical data.
Time frame: Up to 6 months
Circadian analyzes of routine high-output clinical data (Working package 1)
Relevant clinical data (routine and study data), which are associated with circadian rhythmicity
Time frame: Before the start of this investigation
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Charite University, Berlin, Germany