RecruitingOBSERVATIONAL

The Simplify Project

This study, called 'The Simplify Project', is looking into why people with long-term breathing problems, like those with COPD or obesity-related breathing difficulties, often need to go back to hospital after being treated for a flare-up. We think sleep problems, which are often overlooked, might be a big reason for these repeat hospital stays. We want to identify these sleep issues early on. We'll check people's sleep in the hospital and again at home two months later. We're also testing a special breathing mask called a high-flow nasal cannula (HFNC) to see if it can quickly improve sleep issues in some patients. The aim is to understand if better sleep can lead to fewer hospital visits and better health outcomes overall.

At a glance

Status

Recruiting

Sponsor

Unity Health Toronto

Enrolment target

Start

01 Sep 2021

Estimated completion

01 Jul 2026

Acute Hypercapnic Respiratory Failure

What is this study about?

This study, called 'The Simplify Project', is investigating a common and frustrating problem: why do people who have been unwell with a sudden worsening of their breathing condition often end up back in hospital? We know this happens a lot for people with conditions like chronic obstructive pulmonary disease (COPD) or breathing problems linked to obesity, and it can be a real worry for patients and their families.

The researchers believe that sleep problems might be a big part of this puzzle. Many people with these breathing conditions also have sleep issues that might not have been properly diagnosed or treated. These untreated sleep problems could be making it more likely that they'll need to return to hospital. This study wants to find out if there's a clear link between sleep difficulties and needing to go back to the hospital within a year, or even worse outcomes.

To do this, the study will check people's sleep using special equipment both while they are recovering in the hospital and again two months after they've gone home. They will be looking for any signs of disturbed sleep. Additionally, in a smaller group of participants, they will test a special type of breathing support called a high-flow nasal cannula (HFNC). This involves wearing a comfortable mask that delivers warm, moist air at a high flow directly into the nose. The study will see if using this mask for one night can quickly help to improve any sleep problems.

Key takeaways

Looks at why breathing patients return to hospital often.
Investigates the link between sleep problems and hospital readmissions.
Compares sleep while in hospital and two months after discharge.
Tests if a special breathing mask (HFNC) can quickly improve sleep.
Aims to improve care for people with chronic breathing conditions.

Who may be eligible?

To join this study, you need to be an adult who has recently been admitted to hospital as an emergency because of a sudden worsening of your breathing condition, where your body had too much carbon dioxide (this is called acute hypercapnic respiratory failure). You must not normally use a breathing machine at home, and you shouldn't have certain nerve or brain conditions like a spinal cord injury or Alzheimer's. You also shouldn't have had a tracheotomy, and you can't be suffering from extreme obesity.

You won't be able to join if your breathing problem was caused by a drug overdose. Also, if you need a breathing machine before or during the sleep tests, or if your health suddenly gets much worse (like having a stroke or heart attack) during the study, you wouldn't be able to continue.

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 an adult (18 or over)?
Did you recently have an unplanned hospital stay for severe breathing problems?
Do you NOT use an at-home breathing machine normally?
Do you NOT have specific nerve or brain conditions (like Parkinson's, Alzheimer's, or spinal cord injury)?
Was your breathing problem NOT caused by a drug overdose?
Are you NOT considered extremely obese (morbidly obese)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll have your sleep checked twice. The first sleep check will happen while you're still in the hospital, but once you're feeling a bit better (at least two days after being admitted and when your blood pH is stable). For this, you'll wear a small device with wires attached to your head and chest to measure your brain waves and oxygen levels while you sleep, usually from 5 pm to 8 am. The second sleep check will be similar but done at your own home about two months after you've left the hospital.

Additionally, some participants (around 21 people) will have a third sleep check. During this extra check, you'll use a special mask called a high-flow nasal cannula (HFNC) while you sleep for one night. Throughout the study, the team will also review your health records to understand any other health conditions you have and how many times you've been to hospital in the past year. The total time you're actively involved in the study's measurements would be spread over these two (or three for some) sleep study nights and the two-month follow-up period.

Potential risks and benefits

Taking part in this study may help us understand more about how sleep problems affect people with acute breathing difficulties, which could lead to better treatments in the future. While there are no direct health benefits guaranteed from taking part, you might find comfort in contributing to research. The main risks involve the minor inconvenience of wearing the sleep monitoring equipment; it's generally safe and non-invasive. Using the high-flow nasal cannula is also generally safe and common in hospitals. Remember, you can always change your mind and withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

St. Michael's Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'acute hypercapnic respiratory failure'?

It's when your body can't get rid of enough carbon dioxide, leading to a sudden and severe breathing problem that needs hospital treatment.

What is a high-flow nasal cannula (HFNC)?

It's a soft tube that fits into your nostrils and delivers warm, moist air with extra oxygen if needed, at a higher flow than standard oxygen masks.

Will I have to stay in hospital longer if I join?

No, the first sleep test happens once you're stable enough to go home. The study won't keep you in hospital longer than necessary for your clinical care.

What will the sleep study equipment feel like?

The sleep study uses sensors that are placed on your head and body, usually with sticky pads. While it might feel a bit unusual, it shouldn't be painful.

Will I get to see my sleep study results?

The study aims to gather general information from many participants, not to provide individual results. However, you can discuss this with the study team.

How to find out more

Laurent Brochard, MD, PhD

laurent.brochard@unityhealth.to 416-864-5686 Official trial record

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