The Simplify Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: High-flow nasal cannula therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Hypercapnic Respiratory Failure patients with Sleep Disorders<br>Acute Hypercapnic Respiratory Failure patients with Sleep Disorders | Device: High-flow nasal cannula therapy<br>* 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.<br>|
| Acute Hypercapnic Respiratory Failure patients without Sleep Disorders<br>Acute Hypercapnic Respiratory Failure patients without Sleep Disorders | Device: High-flow nasal cannula therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year hospital readmission and 1-year mortality | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 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 | The prevalence of sleep abnormalities during the sleep study performed at the hospital vs. at home. | 15 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Hypercapnic Respiratory Failure, Patient Readmission, Mortality, Sleep Disorders, Intrinsic