The Simplify Project (SIMPLIFY)

May 15, 2025 updated by: Unity Health Toronto

A Strategy to Improve Management and Prolong LIFe Without Readmission for hYpercapnic Patients: The Simplify Project

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will perform sleep studies using nocturnal EEG measurements and oximetry 1) while the participants are still in the hospital but have reached relative clinical stability (≥48 h after admission, not in ICU and pHv ≥7.36) and 2) two months after hospital discharge at the participant's home. Sleep studies will be performed from 5:00 pm to 8 am. EEG measurements will be performed using a portable monitor (Prodigy Sleep System, Cerebra, Winnipeg, Canada). Sleep assessment will be performed offline. The ORP will be continuously quantified and ORP-derived indices will be calculated. Nocturnal oximetry will be used for detecting sleep desaturation episodes. Comorbidities (e.g., obesity, diagnosed lung or heart disease, Charlson comorbidity index) and exacerbations/hospitalization in the previous year will be identified.

In 21 participants, the investigators will perform one additional sleep study with the participants breathing with high-flow nasal cannula therapy (HFNC) to investigate the acute impact (i.e., during one night) of HFNC on reducing sleep abnormalities. HFNC will be set from 25 - 60 L/min based on participant's tolerance and the inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Principal Investigator:
          • Laurent Brochard
        • Sub-Investigator:
          • Antenor Rodrigues
        • Contact:
          • Laurent Brochard, MD, MD, HDR
          • Phone Number: 4168645686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute hypercapnic respiratory failure (pH <7.35 and PaCO2 > 45 mmHg at admission) admitted for an unplanned hospitalization or emergency room visit.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Hypercapnic Respiratory Failure patients with Sleep Disorders
Device: High-flow nasal cannula therapy
High-flow nasal cannula therapy (HFNC) (from 25 - 60 L/min based on patient's tolerance) will be used in 21 participants during one additional sleep study to investigate its acute impact on reducing sleep abnormalities. Inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy.
Acute Hypercapnic Respiratory Failure patients without Sleep Disorders
Device: High-flow nasal cannula therapy
High-flow nasal cannula therapy (HFNC) (from 25 - 60 L/min based on patient's tolerance) will be used in 21 participants during one additional sleep study to investigate its acute impact on reducing sleep abnormalities. Inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year hospital readmission and 1-year mortality
Time Frame: 1 year
The primary endpoint is to compare the rate of 1-year Hospital readmission and mortality between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the home sleep study measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: Through study completion, an average of 1 year
The secondary endpoint is to compare the length of stay during the hospital admission between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Through study completion, an average of 1 year
Need of ventilatory support
Time Frame: Through study completion, an average of 1 year
The secondary endpoint is to compare the need of invasive and non-invasive ventilatory support between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Through study completion, an average of 1 year
Need of ICU admission
Time Frame: Through study completion, an average of 1 year
The secondary endpoint is to compare the need of ICU admission between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Through study completion, an average of 1 year
In-hospital mortality
Time Frame: Through study completion, an average of 1 year
The secondary endpoint is to compare the rate of in-hospital mortality between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Through study completion, an average of 1 year
HFNC effects on sleep depth according to the ORP range
Time Frame: 15 hours
In 21 patients. Time spend in different ORP ranges during the sleep study which the patients used the standard oxygen therapy and the night which the patients used HFNC.
15 hours
Sleep depth according to the ORP during the sleep study performed at the hospital and at home
Time Frame: 15 hours
Time spend in different ORP ranges during the sleep study performed in the hospital vs. at home.
15 hours
HFNC effects on sleep depth according to the AASM criteria
Time Frame: 15 hours
In 21 patients. Time spend in different sleep stages (AASM 2017 rules) during the sleep study which the patients used the standard oxygen therapy and the night which the patients used HFNC.
15 hours
HFNC effects on the prevalence of sleep abnormalities
Time Frame: 15 hours
In 21 patients. The prevalence of sleep abnormalities during the sleep study which the patients used the standard oxygen therapy and the night which the patients used HFNC.
15 hours
Sleep depth according to the AASM at the hospital vs. home
Time Frame: 15 hours
Time spend in different sleep stages (AASM 2017 rules) during the sleep study performed at the hospital vs. at patient's home.
15 hours
Prevalence of sleep abnormalities at the hospital vs. home
Time Frame: 15 hours
The prevalence of sleep abnormalities during the sleep study performed at the hospital vs. at home.
15 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Laurent Brochard, MD, PhD, Unity Health Toronto - St. Michael's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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