Hyperventilation SyndromeWHYNCT03292523
Work Productivity in Hyperventilation Syndrome
An observational study of Hyperventilation Syndrome, run by University Hospital, Lille at 1 site in France.
Trial summary
Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperventilation Syndrome
- What is being tested?
- questionnaire
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2018to 23 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with confirmed hyperventilation syndrome, virgin of any treatment.
Who may be able to join
- Holders of employment contracts for at least 8 days
- Diagnosis of hyperventilation syndrome confirmed by:
- Compatible symptoms and at least two symptoms reproduced by the hyperventilation challenge test: Nijmegen's score> 23 ; Demonstration of alveolar hyperventilation ( Either on rest blood and / or at rest (PaCO2 at rest <36 mmHg and D (A-a) O2 normal; Either during the HV test (increased recovery time of the basic PETCO2 after voluntary hyperventilation (greater than 5 minutes)
Who cannot join
- Existence of another chronic pulmonary disease (asthma, bronchial dilation, COPD, diffuse interstitial pneumonia, neuromuscular pathology ...) or cardiac (rhythm disorder, ischemic heart disease ...) which can participate in dyspnea
- Psychiatric illness / psychotropic treatment
- Pregnancy
- Patient already included in a clinical research protocol involving new therapeutics may not be included in this protocol
- Specific physiotherapy or previous training
Trial locations and contacts
1 site in 1 country.
About this study
Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome
- Conditions
- Hyperventilation Syndrome
- Being tested
- questionnaire
- Keywords
- Hyperventilation syndrome, Work productivity, Absenteeism, Presenteeism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).
| Study group | Role | What they receive |
|---|---|---|
| Hyperventilation syndrome | Not described Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the WPAI score and the Nijmegen score
Measured: At the time of diagnosis (Baseline)
Secondary outcomes (4)
Association between the WPAI score and dyspnea scales
Measured: At the time of diagnosis (Baseline)
Association between the WPAI score and quality of life scores
Measured: At the time of diagnosis (Baseline)
Association between the WPAI score and PaCO2
Measured: At the time of diagnosis (Baseline)
Association between the WPAI score and the Cognitive Failure Questionnaire score
Measured: At the time of diagnosis (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start6 Feb 2018
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperventilation SyndromeStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Chenivesse, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292523
- Sponsor's protocol ID
- 2016_68
- Other IDs
- 2017-A01542-51
- Acronym
- WHY
- Status last verified
- Apr 2022
- First submitted
- 21 Sep 2017
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Productivity in Hyperventilation Syndrome
- ClinicalTrials.gov ID
- NCT03292523
- Acronym / sponsor ID
- WHY / 2016_68
- Conditions
- Hyperventilation Syndrome
- Keywords
- Hyperventilation syndrome, Work productivity, Absenteeism, Presenteeism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 25 Sep 2017 (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.
Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperventilation syndrome | – | Other: questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with confirmed hyperventilation syndrome, virgin of any treatment.
Key inclusion criteria (3 listed)
- Holders of employment contracts for at least 8 days
- Diagnosis of hyperventilation syndrome confirmed by:
- Compatible symptoms and at least two symptoms reproduced by the hyperventilation challenge test: Nijmegen's score> 23 ; Demonstration of alveolar hyperventilation ( Either on rest blood and / or at rest (PaCO2 at rest <36 mmHg and D (A-a) O2 normal; Either during the HV test (increased recovery time of the basic PETCO2 after voluntary hyperventilation (greater than 5 minutes)
Key exclusion criteria (5 listed)
- Existence of another chronic pulmonary disease (asthma, bronchial dilation, COPD, diffuse interstitial pneumonia, neuromuscular pathology ...) or cardiac (rhythm disorder, ischemic heart disease ...) which can participate in dyspnea
- Psychiatric illness / psychotropic treatment
- Pregnancy
- Patient already included in a clinical research protocol involving new therapeutics may not be included in this protocol
- Specific physiotherapy or previous training
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 |
|---|---|---|
| questionnaireWork Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ). | Other | Hyperventilation syndrome |
Primary outcome
Association between the WPAI score and the Nijmegen score
Time frame: At the time of diagnosis (Baseline)
4 secondary outcomes
Association between the WPAI score and dyspnea scales
Time frame: At the time of diagnosis (Baseline)
Association between the WPAI score and quality of life scores
Time frame: At the time of diagnosis (Baseline)
Association between the WPAI score and PaCO2
Time frame: At the time of diagnosis (Baseline)
Association between the WPAI score and the Cognitive Failure Questionnaire score
Time frame: At the time of diagnosis (Baseline)
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 29 Apr 2022.
Related trials for Hyperventilation Syndrome
Not yet recruitingObservational study
Symptomatic Hyperventilation in Individuals Living With Stroke
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RecruitingObservational study
Dysfunctional Breathing in Post COVID-19 Condition.
Post COVID-19 Condition (PCC), Dysfunctional Breathing
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.
Cécile Chenivesse, MD principal investigator
University Hospital, Lille
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 Hyperventilation Syndrome, run by University Hospital, Lille at 1 site in France.
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 5 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 29 Apr 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 France. 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?
Association between the WPAI score and the Nijmegen score (time frame: At the time of diagnosis (Baseline)). 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 29 Apr 2022.