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| Name | Class |
|---|---|
| Koc Healthcare Istanbul American Hospital, Marmara University Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Probability of OSA | Based on a sleep questionnaire |
| |
| Low Probability of OSA | Based on a sleep questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Sleep Apnea Testing or In-hospital Polysomnography | Diagnostic Test | Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term outcomes | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Adults with Covid-19 diagnosis
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| Name | Affiliation | Role |
|---|---|---|
| Yuksel Peker, MD, PhD | Koc University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Hospital | Istanbul | Basibuyuk | Turkey (Türkiye) | |||
| Koc University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33596161 | Derived | Peker Y, Celik Y, Arbatli S, Isik SR, Balcan B, Karatas F, Uzel FI, Tabak L, Cetin B, Baygul A, Ozturk AB, Altug E, Iliaz S, Atasoy C, Kapmaz M, Yazici D, Bayram H, Cetin BD, Caglayan B; OSACOVID-19 Study Collaborators. Effect of High-Risk Obstructive Sleep Apnea on Clinical Outcomes in Adults with Coronavirus Disease 2019: A Multicenter, Prospective, Observational Clinical Trial. Ann Am Thorac Soc. 2021 Sep;18(9):1548-1559. doi: 10.1513/AnnalsATS.202011-1409OC. |
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Individual participant data that underlie the results that will be reported in articles would be available to other researchers by contacting the corresponding authors
Within 6 months after the publications, respectively
Within 6 months after the publications, respectively, for 5 years
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Blood samples
Defined as an increase in category on a 7-category ordinal scale from admission
| 7, 14, 21, 28 days |
| 4-6 months after the initial hospital admission |
| Istanbul |
| TR34010 |
| Turkey (Türkiye) |
| Koc Healthcare Istanbul American Hospital | Istanbul | Turkey (Türkiye) |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |