Actively Recruiting

Age: 18Years +
All Genders
NCT05011877

The Simplify Project

Led by Unity Health Toronto · Updated on 2025-05-20

50

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The high frequency of unplanned hospital visits of patients with chronic hypercapnic respiratory failure (e.g., chronic obstructive pulmonary disease, obesity-related hypoventilation) constitutes a major public health problem. Most patients admitted for acute exacerbations (AHRF) have additional comorbidities, especially sleep disorders. Often untreated, sleep disorders contribute to multiple readmissions (≈70% at one year) and increase readmission costs. The investigators will: 1) identify these patients early during unplanned hospital admissions and perform sleep studies using EEG and oximetry before hospital discharge and two months after to compare sleep abnormalities in the two moments; 2) investigate the association between sleep abnormalities in the two sleep studies with clinical outcomes (1-year readmission and death); 3) investigate the acute effects of high-flow nasal cannula (HFNC) to treat sleep abnormalities as a simplified alternative. The investigators anticipate sleep abnormalities during the hospital stay and two months after discharge will be associated with poor clinical outcomes (readmission, death) and HFNC to acutely reduce sleep abnormalities.

CONDITIONS

Official Title

The Simplify Project

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • No neuromuscular disease such as spinal cord injury
  • No central nervous system disorders including cerebral vascular accident or Alzheimer's disease
  • No tracheotomy
  • Not morbidly obese
Not Eligible

You will not qualify if you...

  • Patients with AHRF due to drug overdose
  • Need for ventilatory support (noninvasive or invasive ventilation) before or during the sleep studies
  • Acute deterioration such as cerebral vascular accident or cardiac arrest before or during the sleep studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

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Research Team

L

Laurent Brochard, MD, PhD

CONTACT

A

Antenor Rodrigues, PT

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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