NCT05934916

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Covid19
• Obstructive Sleep Apnea
• CPAP Ventilation
• Corona Virus Infection

Interventions

Type	Name	Description
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.
DEVICE	oxygen therapy	both groups will receive oxygen

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2023-07-07
• Last updated: 2023-07-07

Locations

1 site across 1 country: Egypt