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New treatment option for Circadian Dysrhythmia
Official title Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention
ClinicalTrials.gov ID: NCT05807178
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in...
- 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)
You likely can't join if
- 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...
- Amaurosis
See the full eligibility 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 ≥ 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.