RecruitingOBSERVATIONAL

Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit

This study is investigating how a medicine named lormetazepam, given continuously, affects the brain activity of critically ill patients in intensive care. Many patients in intensive care have problems with their sleep-wake cycles and can become confused (delirious). Sedatives are often needed, but some can worsen sleep or increase the risk of delirium. Lormetazepam is a newer sedative for continuous use in ICU. This research aims to understand if lormetazepam helps with sleep quality and sedation levels by monitoring brainwave patterns (EEGs). The findings could lead to better ways of choosing and using sedatives for intensive care patients.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

01 Dec 2023

Estimated completion

31 Dec 2024

Critical Illness Delirium Sleep Disorders, Circadian Rhythm

What is this study about?

When people are very unwell and in intensive care, they often need medicines to help them relax or sleep, especially if they are on a breathing machine or experiencing a lot of pain. These medicines are called sedatives. However, finding the right balance with sedatives can be tricky. Sometimes, they can make it harder for patients to sleep properly or can even lead to confusion, also known as delirium. It's a bit like being awake at the wrong times or having very disturbed sleep, which can slow down recovery.

This study focuses on a specific sedative called lormetazepam, which has been approved for continuous use in intensive care more recently. Researchers want to understand exactly how this medicine affects brain activity and sleep patterns in patients. They will use a special test called an EEG (electroencephalography), which involves placing small sensors on the scalp to record the electrical signals made by the brain. By looking at these brainwave patterns, the researchers hope to learn if lormetazepam helps patients get better quality sleep and if it keeps them calmly sedated without being too deep.

The main goal is to gather information that can help doctors make better choices about which sedatives to use and how to give them. This could potentially improve sleep for critically ill patients, reduce confusion, and help protect their brain health during their time in intensive care. Ultimately, the hope is to support patients' recovery and help them avoid long-term problems that can arise from poor sleep and delirium in the ICU.

Key takeaways

This study investigates how lormetazepam affects brain activity and sleep in critically ill patients.
It uses a non-invasive EEG test to record brainwave patterns.
The goal is to improve understanding of sedation and sleep quality in intensive care.
Participation involves receiving standard lormetazepam treatment and up to three EEG measurements.
Results could help doctors choose and use sedatives more effectively in the future.

Who may be eligible?

To be part of this study, you would need to be an adult (18 years or older) who is currently in intensive care and expected to need lormetazepam continuously for at least 24 hours. You should also be expected to stay in intensive care for at least 48 hours and be on a breathing machine or receiving oxygen support for more than 6 hours. If you are unable to give consent yourself, a legally appointed representative, such as a family member, would need to give permission on your behalf.

There are certain situations that would prevent someone from joining the study. For example, if you have a history of serious brain problems, certain sleep disorders like restless legs syndrome or narcolepsy, or conditions that affect your brain pressure. You also wouldn't be able to take part if you have a known allergy to the materials used for the brainwave sensors, or if you have a condition like active alcohol abuse or suspected brain damage from lack of oxygen. The study also cannot include patients who are very unlikely to survive for more than 24 hours.

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?
Are you expected to receive continuous lormetazepam for at least 24 hours?
Are you expected to stay in intensive care for at least 48 hours?
Are you using mechanical ventilation or high-flow oxygen for over 6 hours?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive lormetazepam as a continuous infusion, which means it will be given constantly through a drip, just like other medicines you might receive in intensive care. The amount of medicine will be decided by your treating doctor, following standard care guidelines.

The main part of your involvement will be having up to three EEG measurements over a 24-hour period. An EEG involves placing small, comfortable sensors on your head to record your brain's electrical activity. These measurements usually take place after you've been receiving lormetazepam for at least two hours, and they might happen at different times during your stay in intensive care. These recordings will help researchers understand your sleep quality and how deeply sedated you are. There are no extra hospital visits or follow-ups involved after you leave the ICU for this study.

Potential risks and benefits

The main potential benefit of taking part in this study is contributing to valuable research that could improve care for future critically ill patients. While there isn't a direct personal benefit expected from participating, the information gathered could lead to better ways of managing sedation and sleep in intensive care, potentially reducing problems like delirium. As for risks, continuous lormetazepam is a standard treatment, and the EEG measurements are generally safe and painless, similar to sticky pads on your skin. Some people might have a mild skin reaction to the electrode gel. You are always free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Charité - Universitätsmedizin Berlin
Verified postcode
Mitte, Germany· Recruiting

Common questions

What is an EEG?

An EEG (electroencephalogram) is a test that uses small sensors placed on your scalp to record the electrical activity of your brain. It's painless and similar to having sticky pads put on your skin.

What is lormetazepam?

Lormetazepam is a medicine often used in intensive care units to help patients relax, reduce anxiety, or aid sleep.

Will I feel anything different because of the study?

You shouldn't feel any direct changes because of the study itself. You'll receive your usual medical care, including lormetazepam if your doctor decides it's appropriate for your treatment. The EEG measurements are non-invasive.

How long will I be in the study?

Your involvement in the study mainly includes several EEG measurements over a 24-hour period while you are receiving lormetazepam in the intensive care unit. There are no long-term follow-ups for this study.

Can I leave the study at any time?

Yes, you or your legal representative can decide to withdraw from the study at any point, and this will not affect the medical care you receive.

How to find out more

Alawi Luetz, Prof.Dr.med

alawi.luetz@charite.de +4930450631208 Official trial record

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