Obstructive Sleep Apnea & Covid-19 Outcomes (OSACOVID-19)
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ClinicalTrials.gov Identifier: NCT04363333 |
Recruitment Status :
Active, not recruiting
First Posted : April 27, 2020
Last Update Posted : February 17, 2021
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Condition or disease | Intervention/treatment |
---|---|
COVID Obstructive Sleep Apnea Pneumonia | Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography |
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.
Study Type : | Observational |
Actual Enrollment : | 320 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Impact of Obstructive Sleep Apnea on Covid-19 Outcomes (OSACOVID-19 Study): A Prospective Observational Cohort Study |
Actual Study Start Date : | April 27, 2020 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | July 31, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
High Probability of OSA
Based on a sleep questionnaire
|
Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography
Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis |
Low Probability of OSA
Based on a sleep questionnaire
|
Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography
Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis |
- The rate of clinical improvement [ Time Frame: 7 days ]Defined as a decline of 2 categories from admission on a 7-category ordinal scale
- The rate of clinical improvement [ Time Frame: 14 days ]Defined as a decline of 2 categories from admission on a 7-category ordinal scale
- The rate of clinical improvement [ Time Frame: 21 days ]Defined as a decline of 2 categories from admission on a 7-category ordinal scale
- The rate of clinical improvement [ Time Frame: 28 days ]Defined as a decline of 2 categories from admission on a 7-category ordinal scale
- Clinical status - improvement [ Time Frame: 7, 14, 21, 28 days ]Time to hospital discharge, ICU discharge, weaning from intubation, weaning from supplemental oxygen, incident pneumonia, ARDS, in-hospital mortality
- Clinical status - worsening [ Time Frame: 7, 14, 21, 28 days ]Defined as an increase in category on a 7-category ordinal scale from admission
- Long-term outcomes [ Time Frame: 4-6 months after the initial hospital admission ]Re-analysis of the correlation of obstructive sleep apnea (objectively verified) severity in terms of apnea-hypopnea index and oxygenation levels with the primary and secondary outcomes as described above (the rate of clinical improvement defined as a decline of 2 categories from admission on a 7-category ordinal scale; time to hospital discharge, ICU discharge, weaning from intubation, weaning from supplemental oxygen, incident pneumonia, ARDS, in-hospital mortality as well as with the lung function, CO-diffusion capacity, cardiac function, CT thorax pathologies, biomarkers (cytokines, polymorphisms) and IgG-antibodies after 4 months.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363333
Turkey | |
Marmara University Hospital | |
Istanbul, Basibuyuk, Turkey | |
Koc University | |
Istanbul, Turkey, TR34010 | |
Koc Healthcare Istanbul American Hospital | |
İstanbul, Turkey |
Study Chair: | Yuksel Peker, MD, PhD | Koc University School of Medicine |
Responsible Party: | Koç University |
ClinicalTrials.gov Identifier: | NCT04363333 |
Other Study ID Numbers: |
2020.140.IRB1.030 |
First Posted: | April 27, 2020 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data that underlie the results that will be reported in articles would be available to other researchers by contacting the corresponding authors |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Within 6 months after the publications, respectively |
Access Criteria: | Within 6 months after the publications, respectively, for 5 years |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID Obstructive Sleep Apnea Pneumonia |
Pneumonia Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiratory Tract Infections Infections Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |