Obstructive Sleep Apnea & Covid-19 Outcomes

• Conditions: Obstructive Sleep Apnea; COVID; Pneumonia
• Interventions: Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography

• Registration Number: NCT04363333
• Lead Sponsor: Koç University

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.

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-23
• Study Start: 2020-04-27
• Study First Posted: 2020-04-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17
• Primary Completion: 2021-05-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low Probability of OSA	Home Sleep Apnea Testing or In-hospital Polysomnography	Based on a sleep questionnaire
High Probability of OSA	Home Sleep Apnea Testing or In-hospital Polysomnography	Based on a sleep questionnaire

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical status - worsening	7, 14, 21, 28 days	Defined as an increase in category on a 7-category ordinal scale from admission
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

Trial Locations

Locations (3)

Marmara University Hospital; 🇹🇷 Istanbul, Basibuyuk, Turkey

Koc Healthcare Istanbul American Hospital; 🇹🇷 İstanbul, Turkey

Koc University; 🇹🇷 Istanbul, Turkey