COVIDOSACOVID-19NCT04363333
Obstructive Sleep Apnea & Covid-19 Outcomes
An observational study of COVID and Obstructive Sleep Apnea, run by Koç University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Obstructive Sleep Apnea, Pneumonia
- What is being tested?
- Home Sleep Apnea Testing or In-hospital Polysomnography
- How many people
- 320 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 27 Apr 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Covid-19 diagnosis
Who may be able to join
- Adult patients with Covid 19 diagnosis
- Ability to read and speak
- Signed informed consent.
Who cannot join
- Subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies
- Subjects with alcohol dependency
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Marmara University Hospital
Istanbul, Basibuyuk
Koc University
Istanbul, TR34010
Koc Healthcare Istanbul American Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID, Obstructive Sleep Apnea, Pneumonia
- Being tested
- Home Sleep Apnea Testing or In-hospital Polysomnography
- Keywords
- COVID, Obstructive Sleep Apnea, Pneumonia
- Medical subject headings
- Sleep Apnea, Obstructive, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Sleep Apnea Testing or In-hospital PolysomnographyDiagnostic test
Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis
| Study group | Role | What they receive |
|---|---|---|
| High Probability of OSA | Based on a sleep questionnaire Receives: Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography | |
| Low Probability of OSA | Based on a sleep questionnaire Receives: Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of clinical improvement
Defined as a decline of 2 categories from admission on a 7-category ordinal scale
Measured: 7 days
The rate of clinical improvement
Defined as a decline of 2 categories from admission on a 7-category ordinal scale
Measured: 14 days
The rate of clinical improvement
Defined as a decline of 2 categories from admission on a 7-category ordinal scale
Measured: 21 days
The rate of clinical improvement
Defined as a decline of 2 categories from admission on a 7-category ordinal scale
Measured: 28 days
Secondary outcomes (2)
Clinical status - improvement
Time to hospital discharge, ICU discharge, weaning from intubation, weaning from supplemental oxygen, incident pneumonia, ARDS, in-hospital mortality
Measured: 7, 14, 21, 28 days
Clinical status - worsening
Defined as an increase in category on a 7-category ordinal scale from admission
Measured: 7, 14, 21, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start27 Apr 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Koc Healthcare Istanbul American Hospital, Marmara University Hospital
- Responsible party
- Sponsor
- Investigators
- Yuksel Peker, MD, PhD, Study chair, Koc University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363333
- Sponsor's protocol ID
- 2020.140.IRB1.030
- Acronym
- OSACOVID-19
- Status last verified
- Feb 2021
- First submitted
- 19 Apr 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results that will be reported in articles would be available to other researchers by contacting the corresponding authors
Publications
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.
PubMed 33596161
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obstructive Sleep Apnea on Covid-19 Outcomes (OSACOVID-19 Study): A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04363333
- Acronym / sponsor ID
- OSACOVID-19 / 2020.140.IRB1.030
- Conditions
- COVID, Obstructive Sleep Apnea, Pneumonia
- Keywords
- COVID, Obstructive Sleep Apnea, Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Koc Healthcare Istanbul American Hospital, Marmara University Hospital
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Probability of OSA | – | Diagnostic Test: Home Sleep Apnea Testing or In-hospital PolysomnographyBased on a sleep questionnaire |
| Low Probability of OSA | – | Diagnostic Test: Home Sleep Apnea Testing or In-hospital PolysomnographyBased on a sleep questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Covid-19 diagnosis
Key inclusion criteria (3 listed)
- Adult patients with Covid 19 diagnosis
- Ability to read and speak
- Signed informed consent.
Key exclusion criteria (2 listed)
- Subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies
- Subjects with alcohol dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Sleep Apnea Testing or In-hospital PolysomnographyHome Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis | Diagnostic test | High Probability of OSA, Low Probability of OSA |
Primary outcome
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
2 secondary outcomes
Clinical status - improvement
Time frame: 7, 14, 21, 28 days
Clinical status - worsening
Time frame: 7, 14, 21, 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 33596161Peker 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results that will be reported in articles would be available to other researchers by contacting the corresponding authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuksel Peker, MD, PhD study chair
Koc University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Obstructive Sleep Apnea, run by Koç University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of clinical improvement (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.