Identifying and treating sleep disorders in patients with acute respiratory failure
A Strategy to Improve Management and Prolong LIFe Without Readmission for hYpercapnic Patients: The Simplify Project
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05011877 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients requiring unplanned hospitalization for acute hypercapnic respiratory failure who are not on home ventilation.
Not a fit: Patients with acute hypercapnic respiratory failure due to drug overdose or those requiring ventilatory support during the study will not benefit.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.