Odds ratio product of sleep EEG as a continuous measure of sleep state.
Magdy Younes, Michele Ostrowski, Marc Soiferman...
https://pubmed.ncbi.nlm.nih.gov/25348125Actively Recruiting
Age: 18Years +
All Genders
ID05011877
A Strategy to Improve Management and Prolong Life Without Readmission for Hypercapnic Patients: The Simplify Project
Led by Unity Health Toronto · Updated on 2025-05-20
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand the role of sleep disorders in patients with acute hypercapnic respiratory failure (AHRF), which often leads to frequent unplanned hospital visits and readmissions. The study focuses on patients hospitalized for AHRF, many of whom have additional health issues including untreated sleep problems that may worsen their outcomes. Researchers will investigate sleep abnormalities during hospital stays and two months after discharge, exploring their link to readmission and mortality within one year. Participants will undergo sleep studies using nocturnal EEG and oximetry twice: once during a stable phase in the hospital and once at home two months after discharge. A portable device will record sleep data from 5:00 pm to 8:00 am. In a smaller group of 21 participants, an additional sleep study will assess how high-flow nasal cannula (HFNC) therapy, delivered at 25 to 60 liters per minute based on tolerance, affects sleep abnormalities during one night. Throughout the study, researchers will collect information on participants' existing health conditions and past hospitalizations. They will monitor clinical outcomes such as hospital readmissions and mortality over one year. Sleep depth and abnormalities will be measured and compared between hospital and home settings. The study will also evaluate the immediate impact of HFNC on sleep quality. Participants will be followed for up to one year to assess these outcomes and the potential benefits of HFNC therapy.
CONDITIONS
Brief Title
The Simplify Project
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients requiring an unplanned hospitalization or emergency room visit due to an acute hypercapnic respiratory failure exacerbation
- Not currently on home noninvasive or invasive ventilation
- No neuromuscular disease such as spinal cord injury
- No central nervous system disorders like stroke or Alzheimer
- No tracheotomy
- Not morbidly obese
You will not qualify if you...
- Patients with acute hypercapnic respiratory failure due to drug overdose
- Need for ventilatory support before or during the sleep studies
- Acute deterioration such as stroke or cardiac arrest before or during the sleep studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Approximately 2 months
Participants undergo sleep studies using nocturnal EEG measurements and oximetry while in the hospital after reaching clinical stability and again at home two months after discharge.
2 sleep study visits: 1 in hospital and 1 at home during night-time hours (5:00 pm to 8:00 am)
Monitoring
Duration - 1 year
Participants are monitored for hospital readmission and mortality, along with other health outcomes, for up to 1 year after initial evaluation.
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
A
Antenor Rodrigues, PT
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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