Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

Charite University, Berlin, Germany2 个研究点分布在 1 个国家目标入组 40 人2026年1月20日

适应症Circadian Dysrhythmia

干预措施Dynamic Light Therapy Device, LSA-1 Dynamic Light Therapy Device, LSA-2

概览

阶段: 不适用
干预措施: Dynamic Light Therapy Device, LSA-1
疾病 / 适应症: Circadian Dysrhythmia
发起方: Charite University, Berlin, Germany
入组人数: 40
试验地点: 2
主要终点: Rhythmicity of melatonin concentration
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2026年1月20日

结束日期

2027年9月30日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Charite University, Berlin, Germany

责任方

Principal Investigator

主要研究者

Claudia Spies

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

Charite University, Berlin, Germany

入排标准

入选标准

•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)

排除标准

•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
•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

研究组 & 干预措施

LSA-1

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

干预措施: Dynamic Light Therapy Device, LSA-1

LSA-2

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

干预措施: Dynamic Light Therapy Device, LSA-2

结局指标

主要结局

Rhythmicity of melatonin concentration

时间窗: 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.

次要结局

Incidence of intensive care unit delirium(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Depth of Sedation(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Level of analgesia 2(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Total amount of sedatives(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
ICU length of stay(Participants will be followed up until ICU discharge, an expected average of 3 days.)
Sepsis(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Sequential Organ Failure Assessment (SOFA-Score)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Simplified Acute Physiology Score (SAPS II)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Medical Research Council (MRC) Score(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Hand strength measurements(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
FIM Score (Functional Independence Measure)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Mean blood glucose (mg/dl)(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(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Delirium Severity(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Level of analgesia 1(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Level of analgesia 3(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Level of analgesia 4(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Level of analgesia 5(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Total amount of opioids(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Duration of ventilation(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Hospital length of stay(Participants will be followed up until hospital dischargean expected average of 7 days.)
Septic shock(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Therapeutic Intervention Scoring System (TISS-28)(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)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Intensive Care Mobility Scale(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Blood glucose variability (SD in mg/dl)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Percentage of time in target glucose range (%)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Insulin requirement (IU/kg/h)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Analysis of the sleep architecture measured by polysomnography 2(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Clock genes(Clock gene expression levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion.)
Metabolomics(Metabolomic measurements be assessed up to 3 (6-9) months.)
Proteomics(Proteomic measurements will be assessed up to 3 (6-9) months.)
Inflammation parameters(Inflammation parameter levels will be assessed up to 3 (6-9) months.)
Post Intensive Care Syndrome (PICS)(Up to 3 (6-9) months)
Analysis of the sleep architecture measured by polysomnography 1(Up to 3 (6-9) months)
MCTQ (Munich Chronotype Questionnaire)(Up to 3 (6-9) months)
Actigraphy(Up to 3 (6-9) months)
Sleep diary(Up to 3 (6-9) months)
Molecular data(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Physiotherapy(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Nutritional Therapy(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Nutritional Therapy Complications(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Target protein intake(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Adherence to the diet plan(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Composition of the administered food(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Daily feeding breaks(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Wheather data(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
Cognition 1(Up to 3 (6-9) months)
Cognition 2(Up to 6 months)
Cognition 3(Up to 3 (6-9) months)
Mental impairments(Up to 3 (6-9) months)
Quality of life 1(Up to 3 (6-9) months)
Quality of life 2(Up to 3 (6-9) months)
Mortality(Up to 6 months)