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

February 16, 2021 updated by: Koç University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, TR34010
        • Koc University
      • İstanbul, Turkey
        • Koc Healthcare Istanbul American Hospital
    • Basibuyuk
      • Istanbul, Basibuyuk, Turkey
        • Marmara University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with Covid-19 diagnosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of clinical improvement
Time Frame: 7 days
Defined as a decline of 2 categories from admission on a 7-category ordinal scale
7 days
The rate of clinical improvement
Time Frame: 14 days
Defined as a decline of 2 categories from admission on a 7-category ordinal scale
14 days
The rate of clinical improvement
Time Frame: 21 days
Defined as a decline of 2 categories from admission on a 7-category ordinal scale
21 days
The rate of clinical improvement
Time Frame: 28 days
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 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
7, 14, 21, 28 days
Clinical status - worsening
Time Frame: 7, 14, 21, 28 days
Defined as an increase in category on a 7-category ordinal scale from admission
7, 14, 21, 28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4-6 months after the initial hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Collaborators

Koc Healthcare Istanbul American Hospital, Marmara University Hospital

Investigators

  • Study Chair: Yuksel Peker, MD, PhD, Koç University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 27, 2020

Primary Completion (ANTICIPATED)

May 31, 2021

Study Completion (ANTICIPATED)

July 31, 2021

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.140.IRB1.030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Time Frame

Within 6 months after the publications, respectively

IPD Sharing Access Criteria

Within 6 months after the publications, respectively, for 5 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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