Covid19NCT05934916
Early Application of Continuous Positive Airway Pressure in Coronavirus Patients at Risk of Obstructive Sleep Apnea
A study testing CPAP ( Continuous positive airway pressure) and oxygen therapy in people with Covid19 and Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Obstructive Sleep Apnea, CPAP Ventilation
- What is being tested?
- CPAP ( Continuous positive airway pressure) and oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Application of Continuous Positive Airway Pressure in (Coronavirus Disease 2019) 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.
Read the detailed description
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
- Being tested
- CPAP ( Continuous positive airway pressure), oxygen therapy
- Keywords
- ( Coronavirus disease 2019), Coronavirus infections, sleep breathing disorder, obstructive sleep apnea
- Medical subject headings
- COVID-19, Sleep Apnea, Obstructive, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 therapyDevice
both groups will receive oxygen
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) group in (Coronavirus disease 2019) patients | Experimental | receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and using Continuous Positive Airway Pressure (CPAP) Receives: Device: CPAP ( Continuous positive airway pressure); Device: oxygen therapy |
| Non-CPAP group | Experimental | Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 Receives: Device: oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival n (%), In hospital mortality , Duration of hospital stay, Need for invasive ventilation
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Aug 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934916
- Sponsor's protocol ID
- MS.21.07.1578.
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Application of Continuous Positive Airway Pressure in (Coronavirus Disease 2019) Patients at Risk of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05934916
- Acronym / sponsor ID
- MS.21.07.1578.
- Keywords
- ( Coronavirus disease 2019), Coronavirus infections, sleep breathing disorder, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) group in (Coronavirus disease 2019) patients | Experimental | Device: CPAP ( Continuous positive airway pressure), Device: oxygen therapyreceive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and using Continuous Positive Airway Pressure (CPAP) |
| Non-CPAP group | Experimental | Device: oxygen therapyNon-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Continuous Positive Airway Pressure (CPAP) group in (Coronavirus disease 2019) patients |
| oxygen therapyboth groups will receive oxygen | Device | Continuous Positive Airway Pressure (CPAP) group in (Coronavirus disease 2019) patients, Non-CPAP group |
Primary outcome
Survival n (%), In hospital mortality , Duration of hospital stay, Need for invasive ventilation
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP ( Continuous positive airway pressure) and oxygen therapy in people with Covid19 and Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival n (%), In hospital mortality , Duration of hospital stay, Need for invasive ventilation (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.