Identifying and treating sleep disorders in patients with acute respiratory failure
Official title: A Strategy to Improve Management and Prolong LIFe Without Readmission for hYpercapnic Patients: The Simplify Project
Run by Unity Health Toronto · NCT05011877 · Data updated 2026-11-12
This study is trying to find out if sleep problems are common in people with severe breathing issues and how these problems affect their recovery and chances of going back to the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | May 20, 2025 |
| Trial ID | NCT05011877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients requiring unplanned hospitalization for acute hypercapnic respiratory failure who are not on home ventilation.
✕Probably not a fit
Patients with acute hypercapnic respiratory failure due to drug overdose or those requiring ventilatory support during the study will not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients experiencing acute hypercapnic respiratory failure, particularly those with chronic conditions like COPD and obesity-related hypoventilation. It aims to identify sleep disorders during unplanned hospital admissions and assess their impact on readmission rates and mortality. Participants will undergo sleep studies using EEG and oximetry both in the hospital and two months post-discharge. Additionally, the study will evaluate the effects of high-flow nasal cannula therapy on sleep abnormalities.
Why it matters
Potential benefit: If successful, this study could lead to improved management of sleep disorders in patients with respiratory failure, potentially reducing hospital readmissions and mortality.
How similar studies have gone: While the approach of assessing sleep disorders in this patient population is relatively novel, similar studies have shown the importance of addressing comorbidities in chronic respiratory conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients requiring an unplanned hospitalization or emergency room visit due to an acute hypercapnic respiratory failure exacerbation (AHRF), not on home noninvasive or invasive ventilation, neuromuscular disease (e.g., spinal cord injury) or central nervous system disorders (e.g., cerebral vascular accident, Alzheimer), absence of tracheotomy, and non-morbidly obese. Exclusion Criteria: * Patients with AHRF due to drug overdose * Ventilatory support (noninvasive or invasive ventilation) is needed before or during the sleep studies or if an acute deterioration (e.g., cerebral vascular accident, cardiac arrest) happens before or during the sleep studies.
Where it's running
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St. Michael's Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Laurent Brochard, MD, PhD — Unity Health Toronto - St. Michael's Hospital
- Study coordinator: Laurent Brochard, MD, PhD
- Email: Laurent.Brochard@unityhealth.to
- Phone: 416-864-5686
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using a closed-loop oxygen controller for high flow oxygen treatment in critically ill adults
This study is testing a new system that automatically adjusts oxygen levels for critically ill adults with breathing problems to see if it helps them breathe better than the usual method.
-
Using different masks to prevent pressure sores in patients with respiratory failure
This study tests if using different types of masks during breathing support can help prevent pressure sores in patients with severe breathing problems.
-
Effects of music therapy on ICU patients on mechanical ventilation
This study is testing if live music therapy can help ICU patients on mechanical ventilation breathe easier and recover faster.
-
Comparing High Flow Nasal Cannula and Non-Invasive Ventilation for COPD Exacerbations
This study is testing whether High Flow Nasal Cannula or Non-Invasive Ventilation works better to help people with COPD feel more comfortable and breathe easier during flare-ups.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.