HEaling LIght Algorithms for the ICU Patient (NCT05556811) | Clinical Trial Compass
CompletedNot Applicable
HEaling LIght Algorithms for the ICU Patient
Germany60 participantsStarted 2022-09-01
Plain-language summary
The purpose of this prospective, randomized controlled trial is to investigate if mechanically ventilated patients who are treated with a Light Scheduling Algorithm with high circadian effective irradiances are better able to preserve and induce physiological melatonin rhythms compared to patients who are treated with an application of lower irradiances.
The investigators will further evaluate the impact on delirium prevalence, stress level and general outcome parameters.
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient capable of giving consent or additionally existing legal caregiver/authorized 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
* Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure \> 6 hours/day or high flow \>30 liters) on the day of ICU admission
Exclusion Criteria:
* Participation in other clinical studies during the study period and ten days before
* 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
* Lacking willingness to save and hand out data within the study
* 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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum melatonin concentration
Timeframe: Plasma melatonin levels will be assessed for a maximum of five 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. (6am, 10am, 2pm, 6pm, 10pm, 2am, 6am).