Electrophysiological analysis of Gamma-Hydroxybutyrate-induced sleep in intensive care patients: A Pilot Double-Blind Randomized Controlled Trial.(GAMMA-SLEEP)
This research study, called GAMMA-SLEEP, is exploring new ways to help adult patients in intensive care units (ICU) get better sleep. Many ICU patients struggle with sleep, and this can slow down their recovery. The study focuses on a medicine called Gamma-Hydroxybutyrate (GHB). Researchers want to find out if GHB can help these patients achieve more deep, restorative sleep, which is important for healing. They will compare GHB to a salt water solution (a dummy treatment) to see if there's a difference. Patients will be monitored closely, including measuring their brain waves during sleep, to understand the effects of the treatment. This is an early-stage study to see if further research into GHB for sleep in ICU patients is worthwhile.
At a glance
What is this study about?
When you're seriously ill and staying in the intensive care unit (ICU), getting good sleep can be very difficult. The constant noise, lights, and medical procedures can all interrupt your sleep patterns. However, deep, refreshing sleep is incredibly important for your body to heal and recover. This study, called GAMMA-SLEEP, is looking into whether a specific medicine, Gamma-Hydroxybutyrate (GHB), might be able to help adult ICU patients get more of this crucial deep sleep.
The researchers want to understand if giving GHB to patients in the ICU can increase the amount of time they spend in the deepest stage of sleep, known as N3 sleep. This N3 sleep is when your body does a lot of its repair work. They will compare GHB with a simple saltwater solution, which acts as a dummy treatment, to see if GHB truly makes a difference. They'll be carefully monitoring participants' sleep using special equipment.
This is a 'Phase II' study, meaning it's an early safety and effectiveness check. If GHB shows promise in helping patients sleep better and is generally safe, it could lead to larger studies in the future. The goal is to find better ways to support the recovery of patients in intensive care by improving their sleep quality.
Key takeaways
- This study evaluates a medicine (GHB) for improving sleep in adult ICU patients.
- It aims to increase deep, restorative sleep (N3 stage).
- Sleep will be monitored using special equipment overnight.
- The study compares GHB to a simple saltwater (dummy) treatment.
- Participation involves close monitoring for both benefits and side effects.
- This is an early-stage study to assess safety and effectiveness.
Who may be eligible?
This study is looking for adult patients who are currently in the intensive care unit (ICU) and have been there for at least two days. It doesn't matter if you are breathing with the help of a machine (ventilator) or not; the researchers believe that sleep problems affect all ICU patients after a couple of days.
To be considered for this study, you must be 18 years old or older. The study includes both men and women. The medical team will carefully check other details about your health to make sure this study is right for you and safe for you to take 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 an adult patient in an intensive care unit (ICU)?
- Have you been in the ICU for at least 48 hours (two days)?
- Have your doctors confirmed that this study is suitable and safe for your health condition?
What does participation involve?
If you decide to take part, you would receive either the study medicine, Gamma-Hydroxybutyrate (GHB), or a salt water solution. Neither you nor your doctors will know which one you are receiving – this is called a 'double-blind' study. Both will be given through a drip (intravenously). Throughout one night, your sleep will be carefully monitored using special equipment that measures your brain waves and other body signals. This is called a polysomnography recording, and it helps the researchers understand the different stages of your sleep and how long you spend in each.
The doctors will also be keeping an eye on other things like how alert you are during the day, if you need less pain medicine, how much you are able to participate in rehabilitation, and any side effects you might experience. The total duration of your active participation, including the overnight monitoring, is usually quite short, often just one night, with follow-up observations of your experience.
Potential risks and benefits
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Common questions
What is Gamma-Hydroxybutyrate (GHB)?
GHB is a medicine being tested in this study to see if it can help seriously ill patients in the intensive care unit get better sleep.
Why is sleep so important in intensive care?
Good, deep sleep helps your body heal and recover, which is very important when you are seriously ill in intensive care.
Will I know if I'm getting the real medicine or the dummy treatment?
No, neither you nor your doctors will know if you're getting the active medicine or a saltwater solution. This helps make the study fair.
What kind of monitoring will happen during the study?
Doctors will use special equipment to measure your brain waves and other body signals while you sleep to understand the quality of your sleep.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any time, and it will not affect the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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