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NCT Number: NCT05934916

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

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.

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Key information

Conditions

Covid19 Apnea COVID-19 CPAP Ventilation Corona Virus Infection Coronaviridae Infections Coronavirus Infections Dyssomnias Infections Lung Diseases Nervous System Diseases Nidovirales Infections Obstructive Sleep Apnea Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Al Dakahlia, Egypt, 35511, Egypt

About this study

steps included

  • 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, …).

  • 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).
  • III. Radiological investigations
  • IV. Laboratory Investigations Blood gases, complete blood picture, etc
  • . 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP ( Continuous positive airway pressure)

Device

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

Device

both groups will receive oxygen

Primary outcomes

  1. Survival n (%), In hospital mortality , Duration of hospital stay, Need for invasive ventilation

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2023
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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