Clinical trial NCT04363333: Obstructive Sleep Apnea & Covid-19 Outcomes
Official title: Impact of Obstructive Sleep Apnea on Covid-19 Outcomes (OSACOVID-19 Study): A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Obstructive Sleep Apnea
Pneumonia
Keywords: COVID
Obstructive Sleep Apnea
Pneumonia
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Koc Healthcare Istanbul American Hospital, Marmara University Hospital
First posted: 2020-04-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with Covid-19 diagnosis

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of clinical improvement
timeFrame: 7 days
measure: The rate of clinical improvement
timeFrame: 14 days
measure: The rate of clinical improvement
timeFrame: 21 days
measure: The rate of clinical improvement
timeFrame: 28 days
Secondary outcomes:
measure: Clinical status - improvement
timeFrame: 7, 14, 21, 28 days
measure: Clinical status - worsening
timeFrame: 7, 14, 21, 28 days
Other outcomes:
measure: Long-term outcomes
timeFrame: 4-6 months after the initial hospital admission
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Hospital
state: Basibuyuk
city: Istanbul
country: Turkey
facility: Koc University
city: İstanbul
country: Turkey
facility: Koc Healthcare Istanbul American Hospital
Study officials:
affiliation: Koc University School of Medicine
name: Yuksel Peker, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.