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Enhancement of Circadian Rhythms in ICU Patients Through Light Intervention

Primary Purpose

Circadian Dysrhythmia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dynamic Light Therapy Device, LSA-1
Dynamic Light Therapy Device, LSA-2
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Circadian Dysrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 5 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

Sites / Locations

  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LSA-1

LSA-2

Arm Description

Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances

Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group).

Outcomes

Primary Outcome Measures

Rhythmicity of melatonin concentration
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.

Secondary Outcome Measures

Clock genes
Prevalence of physiological circadian rhythmicity measured by expression activity of clock genes.
Metabolomics
Prevalence of physiological circadian rhythmicity measured by metabolomic concentrations.
Proteomics
Prevalence of physiological circadian rhythmicity measured by proteomic concentrations.
Inflammation parameters
Prevalence of physiological circadian rhythmicity measured by inflammation parameters (cytokines, chemokines, extracellular mitochondria concentrations.
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)
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))
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)
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.
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.
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.
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.
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.
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.
Total amount of opioids
Total amount of opioids administered per ICU treatment day will be measured in with morphine equivalents for each administered opioids.
Total amount of sedatives
Total amount of sedatives administered per ICU treatment day by dose summation for each sedative.
Duration of ventilation
Duration of invasive and non-invasive ventilation in hours
ICU length of stay
ICU length of stay will be measured in days
Hospital length of stay
Hospital length of stay will be measured in days
Sepsis
Does patient fulfil sepsis criteria (Yes/No)
Septic shock
Does patient fulfil criteria for septic shock (Yes/No)
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.
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.
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.
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.
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).
Hand strength measurements
Hand grip strength is measured with a dynometer.
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.
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
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.
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.
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.
Insulin requirement (IU/kg/h)
The amount of insuline is measured in units (IU).
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).
Analysis of the sleep architecture measured by polysomnography
Binary scale (Positive/Negative). All participants will be undergoing a polysomnography as part of their clinical care in the Post Intensive Care Syndrome ambulance.

Full Information

First Posted
February 23, 2023
Last Updated
July 13, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05807178
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
March 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Dysrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LSA-1
Arm Type
Experimental
Arm Description
Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances
Arm Title
LSA-2
Arm Type
Active Comparator
Arm Description
Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group).
Intervention Type
Device
Intervention Name(s)
Dynamic Light Therapy Device, LSA-1
Intervention Description
Dynamic Light Therapy
Intervention Type
Device
Intervention Name(s)
Dynamic Light Therapy Device, LSA-2
Intervention Description
Dynamic Light Therapy
Primary Outcome Measure Information:
Title
Rhythmicity of melatonin concentration
Description
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.
Time Frame
Plasma melatonin levels will be assessed for a maximum of five 24-hour periods.
Secondary Outcome Measure Information:
Title
Clock genes
Description
Prevalence of physiological circadian rhythmicity measured by expression activity of clock genes.
Time Frame
Clock gene expression levels will be assessed for a maximum of five 24-hour periods.
Title
Metabolomics
Description
Prevalence of physiological circadian rhythmicity measured by metabolomic concentrations.
Time Frame
Metabolomic measurements be assessed for a maximum of five 24-hour periods.
Title
Proteomics
Description
Prevalence of physiological circadian rhythmicity measured by proteomic concentrations.
Time Frame
Proteomic measurements will be assessed for a maximum of five 24-hour periods.
Title
Inflammation parameters
Description
Prevalence of physiological circadian rhythmicity measured by inflammation parameters (cytokines, chemokines, extracellular mitochondria concentrations.
Time Frame
Inflammation parameter levels will be assessed for a maximum of five 24-hour periods.
Title
Incidence of intensive care unit delirium
Description
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)
Title
Delirium-free days in the intensive care unit
Description
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)
Title
Delirium Severity
Description
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)
Title
Depth of Sedation
Description
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)
Title
Level of analgesia 1
Description
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)
Title
Level of analgesia 2
Description
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)
Title
Level of analgesia 3
Description
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)
Title
Level of analgesia 4
Description
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)
Title
Level of analgesia 5
Description
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)
Title
Total amount of opioids
Description
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)
Title
Total amount of sedatives
Description
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)
Title
Duration of ventilation
Description
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)
Title
ICU length of stay
Description
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.
Title
Hospital length of stay
Description
Hospital length of stay will be measured in days
Time Frame
Participants will be followed up until hospital dischargean expected average of 7 days.
Title
Sepsis
Description
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)
Title
Septic shock
Description
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)
Title
Sequential Organ Failure Assessment (SOFA-Score)
Description
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)
Title
Simplified Acute Physiology Score (SAPS II)
Description
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)
Title
Therapeutic Intervention Scoring System (TISS-28)
Description
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)
Title
Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II)
Description
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)
Title
Medical Research Council (MRC) Score
Description
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)
Title
Hand strength measurements
Description
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)
Title
Intensive Care Mobility Scale
Description
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)
Title
FIM Score (Functional Independence Measure)
Description
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)
Title
Mean blood glucose (mg/dl)
Description
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)
Title
Blood glucose variability (SD in mg/dl)
Description
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)
Title
Percentage of time in target glucose range (%)
Description
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)
Title
Insulin requirement (IU/kg/h)
Description
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)
Title
Post Intensive Care Syndrome (PICS)
Description
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 6 months
Title
Analysis of the sleep architecture measured by polysomnography
Description
Binary scale (Positive/Negative). All participants will be undergoing a polysomnography as part of their clinical care in the Post Intensive Care Syndrome ambulance.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Circadian analyzes of routine high-output clinical data (Working package P1)
Description
Relevant clinical data (routine and study data), which are associated with circadian rhythmicity
Time Frame
Before the start of this investigation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ≥ 5 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Spies, MD, Prof.
Phone
+49 30 450 55 11 02
Email
claudia.spies@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD, Prof.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD, Prof.
Phone
+49 30 450 55 11 02
Email
claudia.spies@charite.de
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD,Prof.
First Name & Middle Initial & Last Name & Degree
Andreas Edel, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancement of Circadian Rhythms in ICU Patients Through Light Intervention

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