Obstructive Sleep Apnea & Covid-19 Outcomes

Obstructive Sleep Apnea Clinical Trial

— OSACOVID-19  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04363333
• Other study ID #: 2020.140.IRB1.030
• Status: Active, not recruiting
• Start date: April 27, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2021
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: July 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• COVID
• Obstructive Sleep Apnea
• Pneumonia
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Turkey	Koc Healthcare Istanbul American Hospital	Istanbul
Turkey	Koc University	Istanbul
Turkey	Marmara University Hospital	Istanbul	Basibuyuk

Sponsors (2)

Lead Sponsor	Collaborator
Koç University	Koc Healthcare Istanbul American Hospital, Marmara University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term outcomes	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
Primary	The rate of clinical improvement	Defined as a decline of 2 categories from admission on a 7-category ordinal scale	7 days
Primary	The rate of clinical improvement	Defined as a decline of 2 categories from admission on a 7-category ordinal scale	14 days
Primary	The rate of clinical improvement	Defined as a decline of 2 categories from admission on a 7-category ordinal scale	21 days
Primary	The rate of clinical improvement	Defined as a decline of 2 categories from admission on a 7-category ordinal scale	28 days
Secondary	Clinical status - improvement	Time to hospital discharge, ICU discharge, weaning from intubation, weaning from supplemental oxygen, incident pneumonia, ARDS, in-hospital mortality	7, 14, 21, 28 days
Secondary	Clinical status - worsening	Defined as an increase in category on a 7-category ordinal scale from admission	7, 14, 21, 28 days