RecruitingOBSERVATIONAL

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

This study explores the connection between airflow through the nose and sleep quality in patients who have a tracheotomy (a breathing tube in their windpipe) and need a ventilator to help them breathe. When air can't flow through the nose, as happens with a tracheotomy, it might affect how the brain works during sleep. Previous research suggests that simply breathing through the nose helps brain activity and thinking skills. The study aims to see if using a special device to send humidified airflow through the nose could improve sleep quality in these patients, particularly by increasing the amount of REM sleep they get. This research could help us understand better ways to support the overall well-being of patients on ventilators.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

10 Apr 2025

Estimated completion

13 Apr 2026

Patients With Prolonged Weaning

What is this study about?

When we breathe normally through our nose, the air flowing through creates gentle rhythms that travel to our brain. This helps wake up certain parts of the brain and is linked to better thinking and focus. However, if someone has a breathing tube (tracheotomy) and is on a ventilator, the air goes straight into their windpipe, bypassing their nose entirely. This means they can't smell, but it might also affect how their brain functions and their sleep.

This study is looking into whether bringing back this nasal airflow could help these brain activities and improve sleep. Researchers believe that by using a device to gently pass humidified air through the nose of patients with a tracheotomy and who need a ventilator, they might see improvements in their sleep quality, especially in deep, dreaming sleep (called REM sleep).

If the study finds that restoring nasal airflow does indeed improve sleep and brain activity, it could lead to new ways to help patients with tracheotomies who are on ventilators. It could make a real difference to their comfort and overall recovery by supporting better sleep, which is so important for health.

Key takeaways

This study explores how nasal airflow affects sleep in patients with tracheotomies on ventilators.
Bypassing the nose may impact brain activity and sleep.
The study aims to improve sleep quality, especially REM sleep, by restoring nasal airflow.
Participants will have two sleep study nights, one with and one without nasal airflow.
The findings could lead to better support for ventilated patients' well-being.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and currently in a special unit to help you gradually come off a ventilator. You must have a tracheotomy and use a ventilator at night. Your care team also needs to believe that a sleep study (polysomnography) would be helpful for you.

There are also some reasons why you might not be able to join. For example, if you have certain brain conditions like a stroke or epilepsy, or if you have specific mental health conditions. You also can't take part if you have a fever, are very agitated, or are regularly taking strong sedatives. Pregnant or breastfeeding women are also unable to participate. Your doctor will be able to tell you if you meet the specific requirements.

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?
Do you have a tracheotomy and use a ventilator at night?
Are you currently undergoing treatment to come off a ventilator?
Do you have any serious brain or mental health conditions?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have two special sleep study nights that will happen one after the other. During these nights, you’ll have a standard sleep study called a polysomnography, which involves monitors to track your brain waves, breathing, heart rate, and muscle activity while you sleep. On one of these nights, a device will gently send humidified airflow through your nose while you’re on your ventilator. On the other night, you’ll have the sleep study without this nasal airflow. The order of these two nights (which one comes first) will be randomly decided. You won't be given any new medications relating to the study. The total duration of your active participation will be these two nights.

Potential risks and benefits

Participating in research always comes with potential benefits and some small risks. A potential benefit of taking part could be improved sleep quality. While there are no known major risks associated with a nasal airflow device, there's always a small chance of minor discomfort from the monitoring equipment during the sleep studies. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Pitié Salpétrière HOSPITAL
Verified postcode
Paris, France· Recruiting

Common questions

What is a tracheotomy?

A tracheotomy is when a small opening is made in your neck to put in a breathing tube (called a tracheostomy tube) to help you breathe.

What is a ventilator?

A ventilator is a machine that helps you breathe by gently pushing air into your lungs.

What is REM sleep?

REM sleep is a stage of sleep when you often have vivid dreams. It's considered a very important part of a good night's rest.

Will this study affect my normal ventilator treatment?

No, the study won't change your usual ventilator settings or treatment. The nasal airflow device is an addition being tested.

Will I have to pay to be in this study?

No, you will not have to pay to participate in this study. All study-related procedures will be covered.

How to find out more

Martin Dres, MD, PhD

martin.dres@aphp.fr 0142167809 Official trial record

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