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The Simplify Project

Launched by UNITY HEALTH TORONTO · Aug 16, 2021

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Acute Hypercapnic Respiratory Failure Patient Readmission Mortality Sleep Disorders, Intrinsic

ClinConnect Summary

The Simplify Project is a clinical trial aimed at understanding and improving the health of patients who experience acute hypercapnic respiratory failure, a serious breathing issue. Many patients with this condition, often linked to chronic lung diseases or obesity, face frequent hospital visits, especially when they also have untreated sleep disorders. This study plans to identify these patients during unplanned hospital admissions and conduct sleep studies before they leave the hospital and two months later. By comparing the results, researchers hope to learn how sleep problems may affect patients' chances of returning to the hospital or their overall health. They will also explore whether a treatment called high-flow nasal cannula can help improve sleep issues quickly.

To participate in this trial, individuals must be adults who have been hospitalized unexpectedly for an acute worsening of their breathing condition and are not currently using breathing machines at home. Those with certain neurological issues or who need breathing support during the study will not be eligible. If you join the trial, you can expect to undergo sleep tests during your hospital stay and again after two months to help researchers gather important information about your sleep and health. This study is currently recruiting participants, and all adults aged 65 and older are welcome to apply.

Gender

ALL

Eligibility 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.

About Unity Health Toronto

Unity Health Toronto is a leading healthcare organization dedicated to providing exceptional patient care, advancing medical research, and fostering education in the field of health sciences. Comprising St. Michael's Hospital, St. Joseph's Health Centre, and Providence Healthcare, Unity Health integrates a diverse range of clinical services and innovative research initiatives. The organization is committed to improving health outcomes through collaborative partnerships and community engagement, while upholding the highest standards of ethics and integrity in its clinical trials and research endeavors. By focusing on patient-centered approaches, Unity Health Toronto aims to drive advancements in healthcare and contribute to the well-being of the communities it serves.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Laurent Brochard, MD, PhD

Principal Investigator

Unity Health Toronto - St. Michael's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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