Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05011877

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Hypercapnic Respiratory Failure Dyssomnias Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location status: Recruiting

Location contact

Antenor Rodrigues

SUB_INVESTIGATOR

Laurent Brochard

PRINCIPAL_INVESTIGATOR

Laurent Brochard, MD, MD, HDR

CONTACT

4168645686

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-flow nasal cannula therapy

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antenor Rodrigues, PT

CONTACT

[email protected]

Laurent Brochard, MD, PhD

CONTACT

[email protected]

416-864-5686

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: SIMPLIFY

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2021
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.