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Obstructive Sleep Apnea & Covid-19 Outcomes (OSACOVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363333
Recruitment Status : Active, not recruiting
First Posted : April 27, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
Koc Healthcare Istanbul American Hospital, Marmara University Hospital
Information provided by (Responsible Party):
Koç University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
COVID Obstructive Sleep Apnea Pneumonia Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography

Detailed Description:

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 Design
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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 : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. The rate of clinical improvement [ Time Frame: 7 days ]
    Defined as a decline of 2 categories from admission on a 7-category ordinal scale

  2. The rate of clinical improvement [ Time Frame: 14 days ]
    Defined as a decline of 2 categories from admission on a 7-category ordinal scale

  3. The rate of clinical improvement [ Time Frame: 21 days ]
    Defined as a decline of 2 categories from admission on a 7-category ordinal scale

  4. The rate of clinical improvement [ Time Frame: 28 days ]
    Defined as a decline of 2 categories from admission on a 7-category ordinal scale


Secondary Outcome Measures :
  1. 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

  2. Clinical status - worsening [ Time Frame: 7, 14, 21, 28 days ]
    Defined as an increase in category on a 7-category ordinal scale from admission


Other Outcome Measures:
  1. 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
Blood samples

Eligibility Criteria
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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
Study Population
Adults with Covid-19 diagnosis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Turkey
Marmara University Hospital
Istanbul, Basibuyuk, Turkey
Koc University
Istanbul, Turkey, TR34010
Koc Healthcare Istanbul American Hospital
İstanbul, Turkey
Sponsors and Collaborators
Koç University
Koc Healthcare Istanbul American Hospital, Marmara University Hospital
Investigators
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Study Chair: Yuksel Peker, MD, PhD Koc University School of Medicine
More Information
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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: July 23, 2020
Last Verified: July 2020
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Koç University:
COVID
Obstructive Sleep Apnea
Pneumonia
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Pneumonia
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Lung Diseases
Respiratory Tract Infections