Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorUnity Health Toronto
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedSeptember 1, 2021
Main results expectedJuly 1, 2026
Study endsJuly 1, 2026
Registry record updatedMay 20, 2025
Trial IDNCT05011877 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

  • St. Michael's Hospital
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.