Obstructive Sleep Apnea & Covid-19 Outcomes

Study Overview
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Brief Summary
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Covid-19 infection is an on-going pandemic with worse diagnosis in adults with comorbid conditions such as hypertension and cardiopulmonary diseases. Obstructive sleep apnea (OSA) is common in those comorbidities and may contribute to worse prognosis for the Covid-19 cases.

Detailed Description
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The investigators' primary aim is to address the association between the high probability of having OSA and Covid-19 outcomes within 28 days of the hospitalization. Secondary outcomes will be conducting a polysomnography in cases with high probability of having OSA compared to those with low probability, approx. 4 months after the Covid-19 diagnosis, and re-evaluate the association of the verified OSA diagnosis and severity with the outcomes in the first 4 weeks as well as with the outcomes after 4 months.

Official Title
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Impact of Obstructive Sleep Apnea on Covid-19 Outcomes (OSACOVID-19 Study): A Prospective Observational Cohort Study

Conditions
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COVID, Obstructive Sleep Apnea, Pneumonia

Intervention / Treatment
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* Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with Covid 19 diagnosis Ability to read and speak Signed informed consent. Exclusion Criteria: Subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies Subjects with alcohol dependency

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 |
| --- | --- |
| High Probability of OSA<br>Based on a sleep questionnaire | Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography<br>* Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis<br>|
| Low Probability of OSA<br>Based on a sleep questionnaire | Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography<br>* Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of clinical improvement | Defined as a decline of 2 categories from admission on a 7-category ordinal scale | 7 days | 
| The rate of clinical improvement | Defined as a decline of 2 categories from admission on a 7-category ordinal scale | 14 days | 
| The rate of clinical improvement | Defined as a decline of 2 categories from admission on a 7-category ordinal scale | 21 days | 
| The rate of clinical improvement | Defined as a decline of 2 categories from admission on a 7-category ordinal scale | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status - improvement | Time to hospital discharge, ICU discharge, weaning from intubation, weaning from supplemental oxygen, incident pneumonia, ARDS, in-hospital mortality | 7, 14, 21, 28 days | 
| Clinical status - worsening | Defined as an increase in category on a 7-category ordinal scale from admission | 7, 14, 21, 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, Obstructive Sleep Apnea, Pneumonia