Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Hypoxic ventilatory response (HVR): Effect of Esketamine

This study, called 'Hypoxic ventilatory response: Effect of Esketamine', aims to understand how our bodies react to low oxygen levels when a medicine called esketamine is present. Doctors are looking at how breathing changes, and they will also check for any side effects, like unusual thoughts or feelings, that might occur during the period of low oxygen. They will also measure how much esketamine is in the blood. This research involves healthy volunteers and is a later-stage study, meaning the drug has already been tested for safety. The information gained will help medical professionals better understand how esketamine works in the body and its potential effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Leiden University Medical Center

Enrolment target

Start

12 Jun 2023

healthy volunteers

What is this study about?

This research is trying to understand something called the 'hypoxic ventilatory response'. Simply put, this is how your body automatically adjusts your breathing when there isn't enough oxygen around. Think about climbing a high mountain – your breathing naturally gets deeper and faster. This study specifically wants to see how a medicine named esketamine might change this natural breathing response.

Esketamine is a medicine that can be used for certain conditions, and understanding its full effects is really important. By looking at how it influences breathing, especially under low oxygen conditions, doctors can learn more about its safety and how it works. This knowledge can then help them make better decisions about when and how to use the medicine in the future.

The study also aims to check for any unusual thoughts or feelings, sometimes called 'psychomimetic side effects', that might happen when someone is experiencing low oxygen while taking esketamine. They'll also carefully measure how much esketamine is in the blood at different times. Gathering all this information helps build a complete picture of how esketamine affects the body.

Key takeaways

Study examines how esketamine impacts breathing during low oxygen.
Designed for healthy adult volunteers.
Investigates potential mental side effects of esketamine.
Measures drug levels in the blood for safety.
Results help doctors better understand esketamine's effects.

Who may be eligible?

This study is looking for healthy adults to take part. To be eligible, you must be at least 18 years old – there's no upper age limit, as long as you meet the other health criteria.

Both men and women can participate in this research. The most important thing is that you are generally healthy and don't have any medical conditions that would make taking part unsafe or interfere with the results of the study.

Specific medical checks will be done to make sure you are suitable. This ensures the study is as safe as possible for everyone involved and that the results are clear and accurate.

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 generally in good health?
Are you open to having medicines given by injection or drip?
Can you commit to study visits and monitoring?
Do you understand you'll undergo controlled low oxygen periods?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given some medicines. These include Remifentanil, which is a pain reliever, normal saline (a salt water solution), Naloxone, which can reverse the effects of some pain medications, and Esketamine. These will likely be given through an injection or infusion (a drip into your arm).

The main part of the study involves periods where your breathing will be monitored closely, especially when there are controlled low oxygen levels. During these times, researchers will observe how your body reacts. You'll also be asked about any unusual thoughts or feelings you might experience.

Throughout the study, blood samples will be taken to measure the levels of esketamine in your system. The total duration of your involvement will be clearly explained before you agree to participate, including how many visits and how long each visit might be.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that it helps doctors understand more about how medicines like esketamine work, which could eventually improve patient care. You might also receive careful medical monitoring. Potential risks could include side effects from the medicines, discomfort during the low oxygen tests, or side effects like unusual thoughts or feelings. You will be fully informed of all known risks before deciding to join, and you have the right 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
Netherlands

Common questions

What is 'hypoxic ventilatory response'?

It's your body's natural way of changing how you breathe when there isn't enough oxygen, like breathing faster or deeper.

What is esketamine?

Esketamine is a medicine, and this study aims to understand how it affects your breathing and your mind.

Will I feel unwell during the low oxygen part?

The low oxygen periods are carefully controlled and monitored. You will be looked after by medical staff throughout.

Will I get paid for taking part?

The study will provide details on whether you will be reimbursed for your time and travel expenses.

Who is funding this study?

The information about the study's sponsor or funding source will be provided to you by the research team.