Early Application of Continuous Positive Airway Pressure in Coronavirus Patients at Risk of Obstructive Sleep Apnea

Covid19 Clinical Trial

Official title:

Early Application of Continuous Positive Airway Pressure in (Coronavirus Disease 2019) Patients at Risk of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05934916
• Other study ID #: MS.21.07.1578.
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was an experimental clinical trial, Aim: To evaluate the role of early use of Continuous Positive Airway Pressure (CPAP) in management of moderate to severe Coronavirus disease 2019 patients at risk of Obstructive Sleep Apnea, enrolled patients are randomized into two equal groups;Non- CPAP group and CPAP group. Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and CPAP group as in Non-CPAP group plus using CPAP.

Description:

steps included

1. Clinical Assessment:

Full history taking were taken from the enrolled Coronavirus disease 2019patients including age, occupation, medical history and special habits), Coronavirus disease 2019 symptoms (e.g., fever, dyspnea, fatigue, loss of smell or taste, (gastrointestinal tract) symptoms….) as well as all obstructive sleep apnea symptoms (e.g., Snoring, Insomnia, Excessive day time sleepiness, witnessed apnea, …).

2. II. Scales & Questionnaires:

• Epworth Sleepiness Scale (ESS) It's designed to assess the degree of daytime sleepiness.

• - Berlin Questionnaire

• - (Snoring, Tiredness, observed apnea, high blood pressure, body mass Index, age, neck circumference and male Gender questionnaire: This scoring system composed of 8 items that are graded from 0 to 8 according to Yes/No responses (score: 1/0).

3. III. Radiological investigations

4. IV. Laboratory Investigations Blood gases, complete blood picture, etc

5. . CPAP application Auto-CPAP with continuous nocturnal administration or at least4- 6hours /night and during day naps, for more than 70% of nights from the first night of admission to isolation center

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients age above 18 years, diagnosed with moderate to severe (Coronavirus disease 2019) and at risk of Obstructive Sleep Apnea as well as confirmed nasopharyngeal swab positive for (Severe acute respiratory syndrome coronavirus 2) ( by (polymerase chain reaction).

Exclusion Criteria:

• patients were excluded from the study if their age <18 years, hypercapnic, unstable cardiorespiratory (shock) status or respiratory arrest and if there are any contraindications for ( Continuous Positive Airway Pressure (CPAP) mask use

Related Conditions & MeSH terms

• Apnea
• Corona Virus Infection
• Coronavirus Infections
• Covid19
• CPAP Ventilation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP ( Continuous positive airway pressure)
The enrolled eighty patients were simply randomized into two equal groups: Non-CPAP group and CPAP group using a computer-generated table of random numbers. The group allocation was concealed in sequentially numbered, sealed, and opaque envelopes. Patients were selected from isolation center in Mansoura University hospital,Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and CPAP group as in Non-CPAP group plus using CPAP.
• oxygen therapy
both groups will receive oxygen

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Al Dakahlia, Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival n (%), In hospital mortality , Duration of hospital stay, Need for invasive ventilation		8 months