Disease, InfectiousNCT04326114
Effectiveness and Safety of Respiratory Training in the Prevention and Severity of COVID-19
A study testing Inspiratory training device and Expiratory training device in people with Disease, Infectious and Respiratory Disease, run by Universidad Complutense de Madrid.
Trial summary
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease, Infectious, Respiratory Disease, Safety Issues
- What is being tested?
- Inspiratory training device and Expiratory training device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 26 Jul 2020to 20 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
Who cannot join
- Drugs
- Surgery
- Neurology diseases
- Rheumatic diseases
- Systemic diseases
- Smokers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.
- Conditions
- Disease, Infectious, Respiratory Disease, Safety Issues, Effectiveness
- Being tested
- Inspiratory training device, Expiratory training device
- Medical subject headings
- Communicable Diseases, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory training deviceDevice
Inspiratory training by a Power-breath device
Expiratory training deviceDevice
Expiratory training a Winner-flow device
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory training | Experimental | Not described Receives: Device: Inspiratory training device |
| Expiratory training | Experimental | Not described Receives: Device: Expiratory training device |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 disease diagnosis
Dichotomous categorical variable measured by "yes" or "no" responses
Measured: Change from Baseline COVID-19 disease diagnosis at 8 weeks
Secondary outcomes (2)
COVID-19 disease symptoms severity
Dichotomous categorical variable measured by "slight" or "severe" responses
Measured: Change from Baseline COVID-19 disease symptoms severity at 8 weeks
Adverse effects
Polytomous categorical variable measured by adverse effects responses
Measured: Change from Baseline adverse effects at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start26 Jul 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease, InfectiousStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326114
- Sponsor's protocol ID
- Covid_ISCIII 20/265-E_BS
- Status last verified
- Jun 2020
- First submitted
- 26 Mar 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04326114
- Acronym / sponsor ID
- Covid_ISCIII 20/265-E_BS
- Conditions
- Disease, Infectious, Respiratory Disease, Safety Issues, Effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 26 Jul 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 30 Mar 2020 (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.
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory training | Experimental | Device: Inspiratory training device |
| Expiratory training | Experimental | Device: Expiratory training device |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (6 listed)
- Drugs
- Surgery
- Neurology diseases
- Rheumatic diseases
- Systemic diseases
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 |
|---|---|---|
| Inspiratory training deviceInspiratory training by a Power-breath device | Device | Inspiratory training |
| Expiratory training deviceExpiratory training a Winner-flow device | Device | Expiratory training |
Primary outcome
COVID-19 disease diagnosis
Time frame: Change from Baseline COVID-19 disease diagnosis at 8 weeks
Dichotomous categorical variable measured by "yes" or "no" responses
2 secondary outcomes
COVID-19 disease symptoms severity
Time frame: Change from Baseline COVID-19 disease symptoms severity at 8 weeks
Adverse effects
Time frame: Change from Baseline adverse effects at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory training device and Expiratory training device in people with Disease, Infectious and Respiratory Disease, run by Universidad Complutense de Madrid.
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 6 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: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact César Calvo Lobo, PhD (91 394 1544, cescalvo@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 disease diagnosis (time frame: Change from Baseline COVID-19 disease diagnosis at 8 weeks). 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 2 Jun 2020.