NCT04363333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

April 19, 2020

Last Update Submit

February 16, 2021

Conditions

COVIDObstructive Sleep ApneaPneumonia

Keywords

COVIDObstructive Sleep ApneaPneumonia

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (2)

  • Clinical status - improvement

    7, 14, 21, 28 days

  • Clinical status - worsening

    7, 14, 21, 28 days

Other Outcomes (1)

  • Long-term outcomes

    4-6 months after the initial hospital admission

Study Arms (2)

High Probability of OSA

Based on a sleep questionnaire

Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography

Low Probability of OSA

Based on a sleep questionnaire

Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography

Interventions

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

High Probability of OSALow Probability of OSA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with Covid-19 diagnosis

You may qualify if:

  • Adult patients with Covid 19 diagnosis
  • Ability to read and speak
  • Signed informed consent.

You may not qualify if:

  • Subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies
  • Subjects with alcohol dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Marmara University Hospital

Istanbul, Basibuyuk, Turkey (Türkiye)

Location

Koc University

Istanbul, TR34010, Turkey (Türkiye)

Location

Koc Healthcare Istanbul American Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 33596161DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Sleep Apnea, ObstructivePneumonia

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory Tract InfectionsInfectionsLung Diseases

Study Officials

  • Yuksel Peker, MD, PhD

    Koc University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 27, 2020

Study Start

April 27, 2020

Primary Completion

May 31, 2021

Study Completion

July 31, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results that will be reported in articles would be available to other researchers by contacting the corresponding authors

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Within 6 months after the publications, respectively
Access Criteria
Within 6 months after the publications, respectively, for 5 years

Locations

TU(3)