Obstructive Sleep Apnea & Covid-19 Outcomes

NCT ID: NCT04363333

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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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

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COVID Obstructive Sleep Apnea Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High Probability of OSA

Based on a sleep questionnaire

Home Sleep Apnea Testing or In-hospital Polysomnography

Intervention Type DIAGNOSTIC_TEST

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

Home Sleep Apnea Testing or In-hospital Polysomnography

Intervention Type DIAGNOSTIC_TEST

Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Koc Healthcare Istanbul American Hospital, Marmara University Hospital

UNKNOWN

Sponsor Role collaborator

Koç University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuksel Peker, MD, PhD

Role: STUDY_CHAIR

Koc University School of Medicine

Locations

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Marmara University Hospital

Istanbul, Basibuyuk, Turkey (Türkiye)

Site Status

Koc University

Istanbul, , Turkey (Türkiye)

Site Status

Koc Healthcare Istanbul American Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 33596161 (View on PubMed)

Other Identifiers

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2020.140.IRB1.030

Identifier Type: -

Identifier Source: org_study_id

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