Circadian DysrhythmiaNCT05807178
Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention
A study testing Dynamic Light Therapy Device, LSA-1 and Dynamic Light Therapy Device, LSA-2 in people with Circadian Dysrhythmia, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circadian Dysrhythmia
- What is being tested?
- Dynamic Light Therapy Device, LSA-1 and Dynamic Light Therapy Device, LSA-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Jan 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
- Therapy-refractory blood coagulation disorder and inability to consent are exclusion criteria for a muscle biopsy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte
Berlin, 10117
Claudia Spies, MD, Prof.
Claudia Spies, MD, Prof.
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum
Berlin, 13353
Claudia Spies, MD, Prof.
Claudia Spies, MD,Prof.
About this study
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
- Being tested
- Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Light Therapy Device, LSA-1Device
Dynamic Light Therapy
Dynamic Light Therapy Device, LSA-2Device
Light Exposition
| Study group | Role | What they receive |
|---|---|---|
| LSA-1 | Experimental | Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances Receives: Device: Dynamic Light Therapy Device, LSA-1 |
| LSA-2 | Active comparator | Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group). Receives: Device: Dynamic Light Therapy Device, LSA-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhythmicity of melatonin concentration
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.
Measured: Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion
Secondary outcomes (54)
Clock genes
Prevalence of physiological circadian rhythmicity measured by expression activity of clock genes.
Measured: 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.
Measured: Metabolomic measurements be assessed up to 3 (6-9) months.
Proteomics
Prevalence of physiological circadian rhythmicity measured by proteomic concentrations.
Measured: 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.
Measured: 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)
Measured: 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))
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be followed up until hospital dischargean expected average of 7 days.
Sepsis
Does patient fulfil sepsis criteria (Yes/No)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 3 (6-9) months
Actigraphy
Aktigraphy is measured by ActLumus in a time period of six weeks.
Measured: Up to 3 (6-9) months
Sleep diary
Sleep parameter are documented by a sleep diary in a time period of six weeks.
Measured: Up to 3 (6-9) months
Molecular data
Molecular data from muscle needle biopsies in the morning and evening on a study day
Measured: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Physiotherapy
Physiotherapy is measured by a questionnaire.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to 3 (6-9) months
Cognition 2
Cognition 2 is measured by Animal Naming Test
Measured: Up to 6 months
Cognition 3
Cognition 3 is measured by Trail Making Tests A\&B
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 (6-9) months
Mortality
Mortality is measured by statistical data.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start20 Jan 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian DysrhythmiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of Specific Light Algorithms (Dynamic Lightening Schedule Therapy Devices) to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807178
- Sponsor's protocol ID
- CIRCA-MED-WP2
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention
- ClinicalTrials.gov ID
- NCT05807178
- Acronym / sponsor ID
- CIRCA-MED-WP2
- Conditions
- Circadian Dysrhythmia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of Specific Light Algorithms (Dynamic Lightening Schedule Therapy Devices) to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients
| Arm | Type | Receives |
|---|---|---|
| LSA-1 | Experimental | Device: Dynamic Light Therapy Device, LSA-1Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances |
| LSA-2 | Active comparator | Device: Dynamic Light Therapy Device, LSA-2Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Light Therapy Device, LSA-1Dynamic Light Therapy | Device | LSA-1 |
| Dynamic Light Therapy Device, LSA-2Light Exposition | Device | LSA-2 |
Primary outcome
Rhythmicity of melatonin concentration
Time frame: Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.
54 secondary outcomes
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
Time frame: Metabolomic measurements be assessed up to 3 (6-9) months.
Proteomics
Time frame: Proteomic measurements will be assessed up to 3 (6-9) months.
Inflammation parameters
Time frame: Inflammation parameter levels will be assessed up to 3 (6-9) months.
Incidence of intensive care unit delirium
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
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Delirium Severity
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Depth 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
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Level of analgesia 2
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Level of analgesia 3
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Level of analgesia 4
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Level of analgesia 5
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Total amount of opioids
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Total amount of sedatives
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Duration of ventilation
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
ICU length of stay
Time frame: Participants will be followed up until ICU discharge, an expected average of 3 days.
Hospital length of stay
Time frame: Participants will be followed up until hospital dischargean expected average of 7 days.
Sepsis
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Septic shock
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)
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)
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)
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)
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Medical Research Council (MRC) Score
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Hand strength measurements
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Intensive Care Mobility Scale
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
FIM Score (Functional Independence Measure)
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Mean blood glucose (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)
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 (%)
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Insulin requirement (IU/kg/h)
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Post Intensive Care Syndrome (PICS)
Time frame: Up to 3 (6-9) months
Analysis of the sleep architecture measured by polysomnography 1
Time frame: Up to 3 (6-9) months
Analysis of the sleep architecture measured by polysomnography 2
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
MCTQ (Munich Chronotype Questionnaire)
Time frame: Up to 3 (6-9) months
Actigraphy
Time frame: Up to 3 (6-9) months
Sleep diary
Time frame: Up to 3 (6-9) months
Molecular data
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Physiotherapy
Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Light Therapy Device, LSA-1 and Dynamic Light Therapy Device, LSA-2 in people with Circadian Dysrhythmia, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Spies, MD, Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhythmicity of melatonin concentration (time frame: Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.