RecruitingNAINTERVENTIONAL

CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study

This study is for people with a condition called neurogenic orthostatic hypotension (nOH). If you have nOH, you experience a big drop in blood pressure when you stand up, which can cause dizziness, fainting, and other problems. Our bodies naturally produce carbon dioxide (CO2) when we breathe. This study is testing a simple, new device, like a special mask, that helps you gently breathe in some of your own exhaled CO2. The idea is that increasing the CO2 in your body might help to keep your blood pressure more stable when you stand up. Researchers want to see if this method can improve blood pressure and make it easier for people with nOH to stand without feeling unwell. This is a small pilot study to see if this idea works.

At a glance

Status

Recruiting

Phase

Sponsor

University of Calgary

Enrolment target

Start

30 Jul 2024

Estimated completion

31 Dec 2030

Neurogenic Orthostatic Hypotension Autonomic Failure

What is this study about?

If you have neurogenic orthostatic hypotension (nOH), you know how challenging it can be. It's a long-term condition where your blood pressure drops significantly whenever you stand up. This can cause you to feel dizzy, lightheaded, or even faint, making everyday tasks difficult. This condition is often linked with other health issues, such as Parkinson's disease, diabetes, or spinal cord injuries.

Our bodies naturally produce carbon dioxide (CO2) when we breathe. Previous research has hinted that gently increasing the amount of CO2 in the body might help to stabilise blood pressure, especially when standing. This study is exploring a new, simple way to do this using a device that captures some of the CO2 you breathe out, allowing you to breathe it back in. This creates a small, temporary increase in CO2 levels in your body.

This pilot study aims to find out if using this CO2 rebreather device can effectively improve blood pressure and make it easier for people with nOH to stand up without feeling unwell or fainting. It's an initial step to see if this promising approach could eventually become a new way to help manage nOH. We are focused on understanding how your body reacts to this technique and if it helps your blood pressure stay more stable.

Key takeaways

This study is testing a new way to help people with low blood pressure when standing (nOH).
It uses a device to gently increase carbon dioxide (CO2) in your breath.
The aim is to see if this can stabilise your blood pressure when you stand up.
You'll have two test visits involving tilt table tests.
The study could help find new treatments for nOH in the future.

Who may be eligible?

This study is open to both men and women who are at least 18 years old. To be considered, you must have an official diagnosis of neurogenic orthostatic hypotension from a doctor. We are looking for non-smokers who are able to understand and agree to take part in the study, and who can travel to the testing lab in Calgary, AB.

There are certain reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you won't be able to participate. Also, if you have other serious heart or lung conditions, or illnesses that significantly affect your body's systems (like certain kidney or liver diseases, or dementia), or if you are taking medications that could interfere with the tests, you might not be eligible. We also can't include individuals who have had previous surgeries affecting certain nerves or who might have difficulty following the study instructions.

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 at least 18 years old?
Has a doctor told you that you have neurogenic orthostatic hypotension?
Are you a non-smoker?
Are you able to travel to Calgary, AB, for clinic visits?
Are you not currently pregnant or breastfeeding?
Do you have any severe heart or lung conditions, or other serious health problems?

Answer every question to see your result.

What does participation involve?

If you choose to take part, you'll first receive detailed information about the study to read, and we'll answer all your questions. We'll ask you to sign a consent form before any study procedures begin. You'll complete two main test sessions. During these sessions, you'll lie down and then be gently tilted upwards to a 70-degree angle (almost standing) on a special table. You'll do this once while breathing normal room air and once while using the CO2 rebreather device.

Throughout these tests, we will closely monitor various aspects of your health. This includes your blood pressure, heart rate, how much blood your heart is pumping, and how blood flows to your brain. We'll also ask about any symptoms you experience. We'll collect breath-by-breath information about the oxygen and CO2 levels in your breath, as well as your breathing rate. You might be asked to temporarily pause some of your regular medications that could affect the test results. The total duration of your involvement will be two visits, each lasting a few hours.

Potential risks and benefits

Taking part in this study could offer several potential benefits. While this is primarily a research study, you might personally experience an improvement in your blood pressure and standing tolerance during the tests. More broadly, the information gained could lead to new treatments for people with nOH in the future. The risks involved are generally low, as the CO2 rebreather uses a naturally occurring gas. However, during the tilt tests, you might experience typical nOH symptoms such as dizziness or lightheadedness, which we will closely monitor. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is neurogenic orthostatic hypotension (nOH)?

It's a condition where your blood pressure drops a lot when you stand up, often causing dizziness, lightheadedness, or fainting.

What is a CO2 rebreather?

It's a simple device, like a mask, that helps you breathe in a small amount of the carbon dioxide you exhale, temporarily increasing its level in your body.

Will using the device make me feel strange?

You might notice changes in your breathing, but the goal is to gently increase CO2, not to cause discomfort. We will monitor you closely.

How many times do I have to visit the clinic?

You will need to come for two test sessions, each lasting several hours.

Can I stop participating anytime?

Yes, you have the right to withdraw from the study at any point without it affecting your medical care.

How to find out more

Jacquie Baker, PhD

autonomic.research@ucalgary.ca 4032103819 Official trial record

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