Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Experimental hypothermia using cold ambient temperature and drug-induced inhibition of shivering in awake, healthy volunteers: a crossover, double blinded trial

This study investigates how the human body reacts to cold temperatures and how certain medications can prevent shivering. Healthy adult volunteers will take part in a crossover study, meaning they will experience different conditions at different times. Their body temperature will be carefully lowered to 35°C, or the cooling will last a maximum of three hours. Throughout the process, vital signs and discomfort levels will be closely monitored. The researchers are hoping to learn more about how to manage situations where someone gets too cold, which could help in emergency medical care. All participants are free to withdraw at any time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Helse Bergen HF

Enrolment target

Start

29 Sep 2023

Hypothermia

What is this study about?

This study is designed to help doctors understand more about how our bodies cope when we get very cold, a condition called hypothermia. They want to see if specific medicines can help stop shivering, which is our body's natural way of trying to warm up. By learning how these medicines affect us in a controlled way, researchers hope to find better ways to treat people who become dangerously cold, perhaps after an accident or exposure to harsh weather.

During the study, healthy adult volunteers will have their body temperature carefully lowered. This will be done using cold air, and they will also receive different medications or a placebo (a dummy medicine). Doctors will closely watch their body temperature and other important signs like heart rate and breathing. The goal is to see how effectively the medicines prevent shivering and how the body otherwise reacts to being cold.

This research is in an early stage (Phase II), meaning it's still about exploring and understanding. The results could be very important for developing new treatments and improving emergency care for people experiencing hypothermia.

Key takeaways

This study helps understand how our bodies react to cold temperatures.
It tests medicines that might prevent shivering in cold conditions.
Healthy adult volunteers are needed for this research.
Your body temperature will be carefully lowered and monitored.
The study aims to improve treatments for hypothermia.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. The study is open to both men and women.

As a participant, you'll need to be in good general health, as the study involves your body being exposed to cold temperatures in a controlled environment. The research team will do checks to make sure it's 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 in good general health?
Are you comfortable with your body temperature being lowered under medical supervision?
Are you willing to potentially receive different medicines or a placebo?

Answer every question to see your result.

What does participation involve?

If you take part, you'll visit the study centre, where your body temperature will be carefully lowered using cold air. You'll be given different medicines or a placebo (a dummy medicine) at different times during the study. This is a "crossover" study, meaning you'll get to try different treatments (or placebo) at various points, and neither you nor the study team will know which one you're receiving at a given time (this is called 'double-blinded').

Your body temperature, heart rate, breathing, and other vital signs will be continuously monitored. You might also be asked about how you're feeling, including any discomfort or pain. The cooling will stop if your temperature reaches 35°C, or after a maximum of 3 hours, or if you decide you want to stop.

While the exact number of visits and total duration aren't specified here, because it's a crossover study, it likely involves multiple visits over a period. You will have regular checks throughout and after the cooling process.

Potential risks and benefits

Participating in this study might offer a small benefit by contributing to medical knowledge that could help others in the future. The main risks involve intentionally lowering your body temperature, which will be done very carefully and under close medical supervision to keep you safe. You might feel cold or uncomfortable, and there could be side effects from the medicines, like nausea (feeling sick). You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is hypothermia?

Hypothermia is when your body loses heat faster than it can produce it, causing your core body temperature to drop dangerously low.

Will I feel very cold during the study?

Yes, your body temperature will be intentionally lowered. You will likely feel cold, but the process is carefully controlled and monitored by doctors.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual medicines.

How long will the cooling last?

The cooling will last a maximum of 3 hours, or it will stop sooner if your body temperature reaches 35°C.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, for any reason, and this will not affect your future medical care.