Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

Обзор

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.

Вмешательства

• Устройство Dynamic Light Therapy Device, LSA-1
  Dynamic Light Therapy
• Устройство Dynamic Light Therapy Device, LSA-2
  Light Exposition

Первичные конечные точки

• Rhythmicity of melatonin concentration [Срок оценки: Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion]

Вторичные конечные точки (12)

• Clock genes [Срок оценки: Clock gene expression levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion.]
• Metabolomics [Срок оценки: Metabolomic measurements be assessed up to 3 (6-9) months.]
• Proteomics [Срок оценки: Proteomic measurements will be assessed up to 3 (6-9) months.]
• Inflammation parameters [Срок оценки: Inflammation parameter levels will be assessed up to 3 (6-9) months.]
• Incidence of intensive care unit delirium [Срок оценки: 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 [Срок оценки: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
• Delirium Severity [Срок оценки: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
• Depth of Sedation [Срок оценки: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
• Level of analgesia 1 [Срок оценки: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
• Level of analgesia 2 [Срок оценки: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
• Level of analgesia 3 [Срок оценки: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
• Level of analgesia 4 [Срок оценки: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte — Berlin
• Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Kliniku — Berlin

Идентификаторы

NCT: NCT05807178 · CIRCA-MED-WP2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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