Hyperventilation SyndromeNCT05100290
Predictive Properties of the Hyperventilation Provocation Test for the Diagnosis of the Hyperventilation Syndrome
An observational study of Hyperventilation Syndrome, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The Hyperventilation Provocation Test (HPTest) associated with end-tidal CO2 pressure (PETCO2) measurement is a diagnostic tool for idiopathic hyperventilation syndrome (HVS). However, interpretation of HPTest remains unclear regarding the relevant PETCO2 values to consider and the occurrence of subjective symptoms. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperventilation Syndrome
- What is being tested?
- Hyperventilation Provocation Test (HPTest)
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2018to 31 Dec 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who visited the pulmonary department and performed a HPTest on medical prescription
Who may be able to join
- Anyone over 18 years of age who has completed an HPTest and a Nijmegen questionnaire between 2015 and 2020
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The Hyperventilation Provocation Test (HPTest) associated with end-tidal CO2 pressure (PETCO2) measurement is a diagnostic tool for idiopathic hyperventilation syndrome (HVS). However, interpretation of HPTest remains unclear regarding the relevant PETCO2 values to consider and the occurrence of subjective symptoms.
This case-control study aims to identify accurate HPTest measurements for the diagnosis of HVS, regardless of symptoms occurrence.
Read the detailed description
In a first stage, the investigators will analyze in a prospective way a training cohort of HPTest datas from 74 subjects, involving 37 subjects with complaints and a Nijmegen questionnaire score of ≥23/64 (HVS+) matched on gender, age, height, weight and BMI category with 37 healthy controls without complaints and a Nijmegen questionnaire score of <23/64 (HVS-)(16).
All data will have to be collected by the same equipment and by the same operators in the pulmonology department of the CHU-St Pierre-Brussels between June 2018 and October 2021.
To rule out confounding respiratory pathology, each participant will have completed spirometry and methacholine testing, that will have a result within expected normal values.
For both cohorts, kinetics of the PETCO2 recorded during each of the 3 phases of the HPTest (adaptation, hyperventilation and recovery) will be mathematically modeled by an curvilinear model with the parameters (A, A', a and a') noted from the kinetic equation (TAU) : TAU [PETCO2(t)〖=A+a(1-exp〗^((b-t)/c))]. For any observed differences in parameters between groups, the Area Under Curves will be estimated at the cut-off that offers the best Sensitivity and Specificity. False negative and false positive rates will be estimated.
The probability of a type I error is set at 5%.
In a second stage, in order to confirm/infirm the results, a retrospective validation cohort from another care setting, including subjects without confounding pathology, who completed a Nijmegen questionnaire and a HVTest between 2018 and 2021, will be analysed in the same way than the training cohort.
- Conditions
- Hyperventilation Syndrome
- Being tested
- Hyperventilation Provocation Test (HPTest)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperventilation Provocation Test (HPTest)Diagnostic test
During the HPTest, the subject is comfortably seated in a chair with armrests and breathes in a mouthpiece with a salivary collector and a nasal clamp. Parameters of ventilation and gas exchange are analyzed via an Oxycon ProTM (SN808008) with TripleV-Volume Sensor digital(Jaeger).
The HPTest begins with a 3-minutes adaptation phase during which the patient is asked to "breathe normally". During the 3-minutes of voluntary hyperventilation phase, the patient is asked to increase his tidal volume and support a breath rate of at least 30/min in order to reduce his PETCO2 by at least 50%. During the recovery phase of the HPTest, the patient is invited to regain a "natural breathing" for 5 minutes, without guidance on tidal volume or breath rate.
| Study group | Role | What they receive |
|---|---|---|
| HVS+ | Subjects without documented respiratory or cardiac disease, with a spirometry and metacholine tests within expected values AND with complaints documented by a Nijmegen questionnaire score of ≥23/64 (suspected of idiopathic hyperventilation) Receives: Diagnostic Test: Hyperventilation Provocation Test (HPTest) | |
| HVS- | Healthy controls without documented respiratory or cardiac disease, with a spirometry and metacholine tests within expected values AND without complaints documented by a Nijmegen questionnaire score of <23/64 Receives: Diagnostic Test: Hyperventilation Provocation Test (HPTest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PetCO2 recovery (5min)
PetCO2 at the end (5th minute) of the recovery phase of the HPTest
Measured: 5 minute of recovery
Secondary outcomes (1)
PetCO2 recovery (3min)
PetCO2 at the end (3d minute) of the recovery phase of the HPTest
Measured: 3 minute of recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start15 Jun 2018
- Primary completion15 Oct 2021
- Study completion31 Dec 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles, Hopitaux Iris Sud
- Responsible party
- Sponsor
- Investigators
- Vincent Ninane, Study director, CHU St PIerre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100290
- Sponsor's protocol ID
- B076201836758-1
- Status last verified
- Apr 2022
- First submitted
- 18 Oct 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Properties of the Hyperventilation Provocation Test for the Diagnosis of the Hyperventilation Syndrome
- ClinicalTrials.gov ID
- NCT05100290
- Acronym / sponsor ID
- B076201836758-1
- Conditions
- Hyperventilation Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles, Hopitaux Iris Sud
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Oct 2021 (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.
The Hyperventilation Provocation Test (HPTest) associated with end-tidal CO2 pressure (PETCO2) measurement is a diagnostic tool for idiopathic hyperventilation syndrome (HVS). However, interpretation of HPTest remains unclear regarding the relevant PETCO2 values to consider and the occurrence of subjective symptoms.
This case-control study aims to identify accurate HPTest measurements for the diagnosis of HVS, regardless of symptoms occurrence.
Detailed description
In a first stage, the investigators will analyze in a prospective way a training cohort of HPTest datas from 74 subjects, involving 37 subjects with complaints and a Nijmegen questionnaire score of ≥23/64 (HVS+) matched on gender, age, height, weight and BMI category with 37 healthy controls without complaints and a Nijmegen questionnaire score of <23/64 (HVS-)(16).
All data will have to be collected by the same equipment and by the same operators in the pulmonology department of the CHU-St Pierre-Brussels between June 2018 and October 2021.
To rule out confounding respiratory pathology, each participant will have completed spirometry and methacholine testing, that will have a result within expected normal values.
For both cohorts, kinetics of the PETCO2 recorded during each of the 3 phases of the HPTest (adaptation, hyperventilation and recovery) will be mathematically modeled by an curvilinear model with the parameters (A, A', a and a') noted from the kinetic equation (TAU) : TAU [PETCO2(t)〖=A+a(1-exp〗^((b-t)/c))]. For any observed differences in parameters between groups, the Area Under Curves will be estimated at the cut-off that offers the best Sensitivity and Specificity. False negative and false positive rates will be estimated.
The probability of a type I error is set at 5%.
In a second stage, in order to confirm/infirm the results, a retrospective validation cohort from another care setting, including subjects without confounding pathology, who completed a Nijmegen questionnaire and a HVTest between 2018 and 2021, will be analysed in the same way than the training cohort.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVS+ | – | Diagnostic Test: Hyperventilation Provocation Test (HPTest)Subjects without documented respiratory or cardiac disease, with a spirometry and metacholine tests within expected values AND with complaints documented by a Nijmegen questionnaire score of ≥23/64 (suspected of idiopathic hyperventilation) |
| HVS- | – | Diagnostic Test: Hyperventilation Provocation Test (HPTest)Healthy controls without documented respiratory or cardiac disease, with a spirometry and metacholine tests within expected values AND without complaints documented by a Nijmegen questionnaire score of <23/64 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited the pulmonary department and performed a HPTest on medical prescription
Key inclusion criteria (1 listed)
- Anyone over 18 years of age who has completed an HPTest and a Nijmegen questionnaire between 2015 and 2020
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Hyperventilation Provocation Test (HPTest)During the HPTest, the subject is comfortably seated in a chair with armrests and breathes in a mouthpiece with a salivary collector and a nasal clamp. Parameters of ventilation and gas exchange are analyzed via an Oxycon ProTM (SN808008) with TripleV-Volume Sensor digital(Jaeger). The HPTest begins with a 3-minutes adaptation phase during which the patient is asked to "breathe normally". During the 3-minutes of voluntary hyperventilation phase, the patient is asked to increase his tidal volume and support a breath rate of at least 30/min in order to reduce his PETCO2 by at least 50%. During the recovery phase of the HPTest, the patient is invited to regain a "natural breathing" for 5 minutes, without guidance on tidal volume or breath rate. | Diagnostic test | HVS+, HVS- |
Primary outcome
PetCO2 recovery (5min)
Time frame: 5 minute of recovery
PetCO2 at the end (5th minute) of the recovery phase of the HPTest
1 secondary outcome
PetCO2 recovery (3min)
Time frame: 3 minute of recovery
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 21 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperventilation Syndrome
Not yet recruitingObservational study
Symptomatic Hyperventilation in Individuals Living With Stroke
Stroke, Hyperventilation Syndrome
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.
Vincent Ninane study director
CHU St PIerre
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 Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 21 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 Belgium. 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?
PetCO2 recovery (5min) (time frame: 5 minute of recovery). 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 21 Apr 2022.