OSACOVID-19: Obstructive Sleep Apnea & Covid-19 Outcomes

• Sponsor: Koç University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04363333
• Collaborator: Koc Healthcare Istanbul American Hospital, Marmara University Hospital (Other)
• Enrollment: 320
• Locations: 3
• Anticipated Duration (Months): 15.1
• Patients Per Site: 106.7
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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	Phase
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

• 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: Apr 27, 2020
• Anticipated Primary Completion Date: May 31, 2021
• Anticipated Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm	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

Primary Outcome Measures

1. The rate of clinical improvement [7 days]

   Defined as a decline of 2 categories from admission on a 7-category ordinal scale

2. The rate of clinical improvement [14 days]

   Defined as a decline of 2 categories from admission on a 7-category ordinal scale

3. The rate of clinical improvement [21 days]

   Defined as a decline of 2 categories from admission on a 7-category ordinal scale

4. The rate of clinical improvement [28 days]

   Defined as a decline of 2 categories from admission on a 7-category ordinal scale

Secondary Outcome Measures

1. Clinical status - improvement [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Marmara University Hospital	Istanbul	Basibuyuk	Turkey
2	Koc University	Istanbul		Turkey	TR34010
3	Koc Healthcare Istanbul American Hospital	İstanbul		Turkey

Sponsors and Collaborators

• Koç University
• Koc Healthcare Istanbul American Hospital, Marmara University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Koç University
• ClinicalTrials.gov Identifier: NCT04363333
• Other Study ID Numbers: 2020.140.IRB1.030
• First Posted: Apr 27, 2020
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Pneumonia; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Feb 17, 2021