RecruitingNAINTERVENTIONAL

Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

This study aims to understand if special lighting can help restore healthy sleep-wake cycles (circadian rhythms) in critically ill patients in intensive care units (ICU) who are experiencing delirium, a state of severe confusion. Researchers are comparing two types of dynamic light therapy devices with standard hospital lights. They will measure how these lights affect the patients' bodies, looking at natural sleep hormones like melatonin, and genetic and chemical changes. The goal is to see if regulating light exposure can help reduce confusion and improve recovery for these vulnerable patients. This is a randomised controlled trial, meaning patients will be split into groups by chance to receive either the special lighting or standard lighting.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

20 Jan 2026

Estimated completion

30 Sep 2027

Circadian Dysrhythmia

What is this study about?

When you're ill, especially in intensive care, your body's natural clock (called your circadian rhythm) can get out of sync. This clock controls things like when you naturally feel sleepy or awake, and it also affects many other body functions. Being in an intensive care unit (ICU) can make this worse because of constant lighting, noise, and medical treatments, leading to confusion, known as delirium.

This study is looking into whether using special light devices could help reset this natural body clock for patients in the ICU who are experiencing delirium. The idea is that carefully chosen light exposure throughout the day and night could help their bodies produce important hormones, like melatonin (the sleep hormone), at the right times again. Researchers will be comparing two different types of dynamic light devices with the usual lighting found in hospitals.

The main aim is to see if these special lights can improve how well your body's internal clock works, which might in turn help reduce confusion and improve overall recovery. They will take measurements of things like sleep hormones and other body chemicals to see if the light therapy is having a positive effect. They are essentially exploring a new way to support patients' natural healing processes during a very difficult time.

Key takeaways

Tests if special lights can help very ill, confused patients in ICU.
Aims to fix natural sleep-wake patterns (body clock).
Compares special light devices with standard hospital lighting.
Involves blood tests to measure hormones and other body changes.
May help reduce confusion and improve recovery for ICU patients.

Who may be eligible?

This study is looking for adult patients (aged 18 or over) who are currently in intensive care and are expected to stay there for at least two more days. A key part of being considered for this study is that you must be experiencing confusion (delirium) during your time in the ICU, or have had it within 30 days of being considered for the study. You or a close family member/legal representative must be able to agree to take part.

There are several reasons why someone might not be able to join. For example, if you've already been part of another medical study recently, or if you had significant brain injury, severe heart problems that needed resuscitation, or certain serious eye conditions. Also, if you have a history of major mental health issues, serious liver problems, or if you're pregnant or breastfeeding, this study would not be suitable for you.

The researchers also need to make sure that taking part won't put you at risk. Therefore, if you currently have very high pressure in your brain, are predicted to not survive for more than 24 hours, or if you refuse to take part in any clinical trials, you won't be included. This is all to ensure the safety and well-being of everyone taking part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in intensive care?
Have you been feeling confused recently, or been diagnosed with delirium?
Do you (or your family) agree to take part?
Do you have any serious eye conditions like severe retinopathy or glaucoma?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would stay in your usual intensive care unit. Instead of the standard hospital lights, you would be exposed to either one of the special dynamic light therapy devices or continue with standard lighting, depending on which group you are assigned to by chance. The special lights are designed to change over the day to mimic natural light patterns.

Throughout your time in the study, which is generally while you are in the ICU and experiencing delirium, researchers will monitor your condition closely. They will also take samples, such as blood, to measure things like your sleep hormones (melatonin) and look at how your genes and other body chemicals are reacting to the light. This helps them understand the effects of the intervention. There are no additional hospital visits or follow-up appointments required once you leave the ICU related to this specific study.

Potential risks and benefits

Taking part in this study might offer a potential benefit by helping to re-establish your natural sleep-wake cycle, which could reduce confusion and improve your overall recovery in the intensive care unit. However, as with any study, there are potential small risks. For example, light sensitivity can sometimes cause discomfort, though this is carefully checked for before you join. There might also be a small risk associated with blood tests, such as minor bruising. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte
Verified postcode
Berlin, Germany· Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is 'delirium'?

Delirium is a serious state of confusion that comes on suddenly. It can make you feel disoriented, unable to think clearly, or see things that aren't there. It's common in very unwell patients in intensive care.

What are 'circadian rhythms'?

These are your body's natural 24-hour cycles, often called your 'body clock'. They control when you feel awake or sleepy, and affect many other bodily functions like hormone release and digestion.

Will I know if I'm getting the special lights or regular lights?

Because this is a 'randomised controlled trial', you will be assigned to a group by chance – either one of the special light groups or the standard lighting group. The research team might not tell you which group you are in to ensure the results are fair and unbiased.

Will this study affect my usual medical treatment?

No, this study is designed to explore the effects of lighting and will not interfere with any of the primary medical treatments or care you are receiving for your illness in the intensive care unit.

What if I feel uncomfortable with the lights?

If you or your family/carer notice any discomfort or concerns related to the lighting, please tell the medical team immediately. Your safety and comfort are the top priority, and adjustments can be made.

How to find out more

Claudia Spies, MD, Prof.

claudia.spies@charite.de +49 30 450 55 11 02 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.