ClinicalTrials.gg
CompletedNCT05189158Updated Jan 12, 2022

Ventilatory Responses to Hypercapnic and Hypoxic Conditions in Hyperventilants

An interventional study of Hypercapnic hyperoxic ventilatory response and Hypoxic eucapnic ventilatory response in Hyperventilation Syndrome, Hypercapnia and Hypoxia, sponsored by Centre Hospitalier Universitaire Saint Pierre. Completed at 1 site in Belgium. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by Centre Hospitalier Universitaire Saint Pierre · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

For almost a century, many hypotheses have converged on the idea of altered chemosensitivity in patients suffering from hyperventilation syndrome (HVS).

Given the evolution of current technical equipment and the ability to maximise true positives in HVS ( using the revised hyperventilation provocation test), it seems reasonable to investigate central and peripheral chemosensitivities in HVS subjects.

Read the detailed description

In the inter-war period, many medical investigators who studied the hyperventilation syndrome (HVS) had already questioned the chemosensitivity to CO2 in HVS patients, without being able to explore it for all intents and purposes.

It was subsequently observed that although HVS is not systematically linked to manifest resting hypocapnia, it is nevertheless systematically correlated with significant variability and complexity of ventilation.

This is consistent with the observations of an increased plant gain in HVS, to be related to an increased loop gain (due to instability of controller gain feedback).

On the other hand, some authors already noted that, when capnia is chronically compromised in HVS, it can be greatly altered by small, transient and barely perceptible increases in VE: a 10% increase in VE could indeed halve PetCO2, while a sigh would be able to decrease PetCO2 by up to 15mmHg.

More recently, teh assumption was made that peripheral chemosensitivity may be impaired in HVS patients.

For all these considerations, it seems reasonable to investigate central and peripheral chemosensitivities in identified HVS subjects on the basis of an objective test, such as the induced hyperventilation test.

02

Conditions studied

  • Hyperventilation Syndrome
  • Hypercapnia
  • Hypoxia
03

In context

Hypercapnia

156 studies on the registry are indexed under Hypercapnia; 31 are open to participants now.

This study's enrollment of 24 is below the median of 36 across 120 interventional studies indexed under Hypercapnia.

Browse Hypercapnia studies →

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A plethysmography within subject's predicted values
  • A negative metacholine test (no documented allergy)
  • A hyperventilation provocation test result that is consistent with the Nijmegen questionnaire score, confirming either group classification (HVS+ or HVS-)

Exclusion criteria

Exclusion Criteria:

  • Each of the following known or documented conditions: chronic bronchitis (), emphysema, asthma, cardiac disorder, neurological disorder, gastrointestinal disorder, thyroid disorder or psychological/psychiatric disorder
  • Suspicious cardio-pulmonary exercise testing (CPET) with cardiac or respiratory limitation
  • Pregnant women or women in the process of becoming pregnant
  • Persons with a diving practice (amateur or professional),
  • High-level athletes,
  • Active smokers and
  • persons using morphine, and/or barbiturates, and/or anxiolytics and/or sleeping pills
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    HVS-

    subjects with no complaint AND a Nijmegen questionnaire score of \< 23/64 AND a negative hyperventilation provocation test (criteria revised in 2021) (HVS-)

    Diagnostic Test: Hypercapnic hyperoxic ventilatory response · Diagnostic Test: Hypoxic eucapnic ventilatory response

  • Other
    HVS+

    subjects with complaints AND a Nijmegen questionnaire score of ≥23/64 AND a negative hyperventilation provocation test (criteria revised in 2021) (HVS+)

    Diagnostic Test: Hypercapnic hyperoxic ventilatory response · Diagnostic Test: Hypoxic eucapnic ventilatory response

Interventions

  • Diagnostic testHypercapnic hyperoxic ventilatory response

    The hypercapnic ventilatory response (HCVR) described by Read in 1967 (Read's rebreathing method) is a clinical way to assess the central and peripheric sensitivity to CO2, using a small bag (4-6 l) to achieve prompt equilibrium between the apparatus compartments and the lungs. By rebreathing a hyperoxic mixture with an initial composition of 70% O2, 7% CO2 and 23% N2, this equilibrium is assumed to be achieved after 15 seconds of rebreathing, when the relationship between VE and PetCO2 has become linear.

  • Diagnostic testHypoxic eucapnic ventilatory response

    The hypoxic eucapnic ventilatory response (HOVR) is a clinical way to assess the peripheric chemosensitivity to O2, using a small bag (4-6 l) to rebreathe a gas mixture initially composed of 20% O2, 0% CO2 and Δ% N2. Eucapnia is achieved by the activation of a CO2 reabsorption cell during the course of the test.

06

What researchers measure

Primary outcomes

  1. The slope of the ventilatory response to hypercapnia (HCVR)

    Ventilation increase (litres/min) per unit increase in PetCO2 (mmHg) using Read's method

    Time frame: baseline - during the test

  2. The slope of the ventilatory response to hypoxia (HOVR)

    Ventilation increase (litres/min) per unit decrease in SpO2 (%) using Read's method

    Time frame: baseline - during the test

  3. Ventilatory recruitment threshold (VRT) of the HCVR

    From the average baseline ventilation and PetCO2, the VRT id the PetCO2 level at which the ventilatory response is activated

    Time frame: baseline - during the test

  4. Ventilatory recruitment threshold (VRT) of the HOVR

    From the average baseline ventilation and SpO2, the VRT is the level of SpO2 at which the ventilatory response is activated

    Time frame: baseline - during the test

Secondary outcomes

  1. Extrapolated apnoeic threshold of the HCVR

    PetCO2 level above which apnoea (zero ventilation) is disrupted, obtained from the extrapolation of the HCVR at the X-axis intersection (when VE=0 l/min)

    Time frame: baseline - during the test

  2. Dyspnea

    Visual analogic scale (VAS) of dyspnea, from 0 (no dyspnea) to 10 (maximal dyspnea)

    Time frame: baseline, end of the test

07

Study locations

1 site
  • CHU St Pierre
    Bruxelles, Brabant 1000, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05189158
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
Université Libre de Bruxelles
Responsible party
Sponsor
First posted
Jan 12, 2022
Start date
Oct 15, 2021
Primary completion
Oct 15, 2021
Completion
Oct 15, 2021
Last update
Jan 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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