COVID-19NCT05217875
Prognostic of Dysfunctional Breathing in Long Covid: a Follow up Study
An observational study of COVID-19 and Dysfunctional Breathing, run by Hôpital du Valais at 1 site in Switzerland.
Trial summary
Dysfunctional breathing might participate to dyspnoea in long COVID-19. This study investigate the prognosis of patients diagnosed with dysfunctional breathing after SARS-CoV-2 infection in our center. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- COVID-19, Dysfunctional Breathing
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to Aug 2022
- Phase
- Observational
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - Patients of 14 years or more diagnosed with DB after COVID-19 using a combined approach of symptoms and CPET in the Hospitals of Sion, of Martigny or Rennaz
Who may be able to join
- patients 14 years or more
- diagnosis of DB after SARS-CoV-2 at our long covid clinic using a combined approach of symptoms and CPET analysis in the hospitals of Sion, Martigny or Rennaz
- Inclusion between November 2020 and until the end of October 2021
Who cannot join
- Refusal to participate
- comorbidities preventing the CPET or PFT to be carried out
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Centre hospitalier du valais romand
Martigny-Ville
Pierre-Olivier Bridevaux, Prof, +41792079069, pierre-olivier.bridevaux@hopitalvs.ch
Léon Genecand, Dr, +41799372687, leon.genecand@hcuge.ch
About this study
Dysfunctional breathing might participate to dyspnoea in long COVID-19. This study investigate the prognosis of patients diagnosed with dysfunctional breathing after SARS-CoV-2 infection in our center.
Read the detailed description
Dysfunctional breathing (DB) with or without hyperventilation syndrome (HVS) as diagnosed using cardiopulmonary exercise test (CPET) was recently demonstrated as an important physiopathological mechanism of persistent dyspnoea in long COVID patients [1]. DB is characterized by specific ventilation pattern on CPET accompanied by respiratory discomfort and/or dyspnea at exercise [2]. Most patients with DB will have undergone some sort a specific physiotherapy retraining [3]. However the prognostic and the predictors of persistence/resolution of DB after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are unknown.
The aim of the study is to determine the prognostic of patients diagnosed with DB after SARS-CoV-2 infection, as well as prognosis factors and predictors of persistence/resolution of DB during a prospective follow up visit.
- Conditions
- COVID-19, Dysfunctional Breathing
- Keywords
- COVID-19, Dysfunctional breathing, Hyperventilation syndrome, Sighs, erratic breathing
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence/resolution of dysfunctional breathing at follow-up visit
defined by persistence/resolution of dyspnea, as compared with patient's baseline (equivalent level of dyspnea as before COVID-19).
Measured: 6 to 9 monts from diagnosis
Secondary outcomes (9)
Change in ventilatory patterns (tidal volume [VT], breathing frequency [BF] at isowork as compared with baseline
Measured: 6 to 9 monts from diagnosis
Dispersion of VT and BF during the CPET
Measured: 6 to 9 monts from diagnosis
Change in ETCO2 and PaCO2
Measured: 6 to 9 monts from diagnosis
Qualitative changes (increase/decrease/no change of DB pattern of CPET)
Measured: 6 to 9 monts from diagnosis
Score HADS changes
Measured: 6 to 9 monts from diagnosis
Score SF-36 changes
Measured: 6 to 9 monts from diagnosis
Specific symptom scale changes
Measured: 6 to 9 monts from diagnosis
Specific work capacity changes questions
Measured: 6 to 9 monts from diagnosis
Post-COVID Functional Status (PCFS) changes
Measured: 6 to 9 monts from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Nov 2021
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217875
- Sponsor's protocol ID
- 2021-01698
- Status last verified
- Dec 2021
- First submitted
- 31 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data upon reasonable requests
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic of Dysfunctional Breathing in Long Covid: a Follow up Study
- ClinicalTrials.gov ID
- NCT05217875
- Acronym / sponsor ID
- 2021-01698
- Conditions
- COVID-19, Dysfunctional Breathing
- Keywords
- COVID-19, Dysfunctional breathing, Hyperventilation syndrome, Sighs, erratic breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 1 Feb 2022 (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.
Dysfunctional breathing might participate to dyspnoea in long COVID-19. This study investigate the prognosis of patients diagnosed with dysfunctional breathing after SARS-CoV-2 infection in our center.
Detailed description
Dysfunctional breathing (DB) with or without hyperventilation syndrome (HVS) as diagnosed using cardiopulmonary exercise test (CPET) was recently demonstrated as an important physiopathological mechanism of persistent dyspnoea in long COVID patients [1]. DB is characterized by specific ventilation pattern on CPET accompanied by respiratory discomfort and/or dyspnea at exercise [2]. Most patients with DB will have undergone some sort a specific physiotherapy retraining [3]. However the prognostic and the predictors of persistence/resolution of DB after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are unknown.
The aim of the study is to determine the prognostic of patients diagnosed with DB after SARS-CoV-2 infection, as well as prognosis factors and predictors of persistence/resolution of DB during a prospective follow up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Patients of 14 years or more diagnosed with DB after COVID-19 using a combined approach of symptoms and CPET in the Hospitals of Sion, of Martigny or Rennaz
Key inclusion criteria (3 listed)
- patients 14 years or more
- diagnosis of DB after SARS-CoV-2 at our long covid clinic using a combined approach of symptoms and CPET analysis in the hospitals of Sion, Martigny or Rennaz
- Inclusion between November 2020 and until the end of October 2021
Key exclusion criteria (2 listed)
- Refusal to participate
- comorbidities preventing the CPET or PFT to be carried out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistence/resolution of dysfunctional breathing at follow-up visit
Time frame: 6 to 9 monts from diagnosis
defined by persistence/resolution of dyspnea, as compared with patient's baseline (equivalent level of dyspnea as before COVID-19).
9 secondary outcomes
Change in ventilatory patterns (tidal volume [VT], breathing frequency [BF] at isowork as compared with baseline
Time frame: 6 to 9 monts from diagnosis
Dispersion of VT and BF during the CPET
Time frame: 6 to 9 monts from diagnosis
Change in ETCO2 and PaCO2
Time frame: 6 to 9 monts from diagnosis
Qualitative changes (increase/decrease/no change of DB pattern of CPET)
Time frame: 6 to 9 monts from diagnosis
Score HADS changes
Time frame: 6 to 9 monts from diagnosis
Score SF-36 changes
Time frame: 6 to 9 monts from diagnosis
Specific symptom scale changes
Time frame: 6 to 9 monts from diagnosis
Specific work capacity changes questions
Time frame: 6 to 9 monts from diagnosis
Post-COVID Functional Status (PCFS) changes
Time frame: 6 to 9 monts from diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided. Data upon reasonable requests
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Dysfunctional Breathing, run by Hôpital du Valais at 1 site in Switzerland.
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 3 inclusion and 2 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 1 Feb 2022. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Olivier v Bridevaux (+41792079069, pierre-olivier.bridevaux@hopitalvs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence/resolution of dysfunctional breathing at follow-up visit (time frame: 6 to 9 monts from diagnosis). 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 1 Feb 2022.