Clinical Trial

The Simplify Project

Study acronym: SIMPLIFY
Recruiting
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Record status
This record was last updated May 20, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-08-16.
Status change: Not Yet Recruiting → Recruiting 2025-05-15
Trial Details
NCT Number NCT05011877
Lead Sponsor Unity Health Toronto
Conditions Acute Hypercapnic Respiratory Failure
Enrollment 50 participants
Start Date 2021-09-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-20