Clinical trial NCT03159429: Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome
Official title: Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hyperventilation Syndrome
Keywords: Dyspnea
Rehabilitation of olfaction
Hyperventilation syndrome
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: APARD Fonds de dotation
First posted: 2017-05-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The included population will be randomized into two parallel groups. One group will be assigned the experimental intervention. The other group will be assigned standard care. Outcomes will be compared between the two randomized groups.
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to measure the effect (at 3 months) of dyspnea control rehabilitation with nasal ventilation versus standard rehabilitation, in dyspneic patients with hyperventilation syndrome.

Detailed description: Hyperventilation syndrome (SHV) is a complex disorder of adaptation of ventilation to exercise. This is a frequent reason for consultation because it is associated with major symptoms, which can be a source of sometimes heavy exploration and wandering. The breathless patient reduces his activity and enters the vicious circle of deconditioning. The principal clinical symptom in this pathology is the dyspnea with hypocapnia. The diagnosis is based on quality of life questionnaires and provocation tests, such as stress testing. When hypocapnia becomes chronic, a disturbance of breathing control sets in.

In SHV therapy, control of ventilation to exercise is recommended in the first line. It aims to slow the respiratory rate or tidal volume with, for example, techniques of voluntary hypoventilation and abdominal ventilation. But the evidence of literature is lacking to recommend a particular technique. Given the implication of the dysfunction of the nose, of non-unicist and often multifactorial origin in the respiratory pathologies, one of the possibilities of intervention is to reeducate the patient to the nasal ventilation.

Our rehabilitation of nasal ventilation is based on the clinical observation of hyperventilation dyspnea. During breathlessness breathing is essentially oral. It is a natural mechanism of adaptation that responds to the metabolic demand, which is far too present in the hyperventilation syndrome. From our therapeutic experience, the hypothesis is that the work on nasal ventilation can provide the necessary elements for the correction of SHV. The importance of the nasal breath in managing emotions and effort in sport is already considered.

This study will evaluate pathophysiological and clinical parameters effets of rehabilitation of nasal ventilation compared to those of the technique of voluntary hypoventilation (ThV) which is the conventional management of patients with SHV.

Eligibility criteria: Inclusion Criteria:

* The patient must have given his / her free and informed consent and signed the consent
* The patient must be a member or beneficiary of a health insurance program
* The patient is available for 3 months of follow-up
* The patient has at least two of the following clinical symptoms consistent with hyperventilation sydrome: dyspnea, chest pain or pressure, visual blurring, dizziness, a sensation of abdominal swelling, tingling in the fingers, stiffness in the fingers or arms, tingling sensation around the mouth, cold or moist hands, tension or anxiety
* Resting hypocapnia defined by a PaCO2 \<38 mmHg and a normal O2 alveolo-arterial gradient D (A-a) O2
* Absence of significant obstructive or restrictive pathology according to respiratory function tests
* Absence of indirect signs of pulmonary arterial hypertension according to echocardiography
* Absence of alteration of gas exchange on maximum cardiopulmonary stress test (elevation of gradient D (A-a) O2 \> 35 mmHg at peak stress)
* At least 2 of the following criteria: (i) a Nijmegen questionnaire score \> 23, (ii) the recurrence of at least two common symptoms during the maximum cardiopulmonary stress test, (iii) delayed return of PETCO2 (partial pressure of end-tidal carbon dioxide) to its basal value (\> 5 minutes)

Exclusion Criteria:

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The subject is under judicial protection, or is an adult under any kind of guardianship
* The subject refuses to sign the consent
* It is impossible to correctly inform the subject
* The subject cannot fluently read French
* The patient is pregnant
* The patient is breastfeeding
* The subject has a contra-indication (or an incompatible drug association) for a treatment required during this study (a priori, there are no contra-indicated drugs)

Primary outcomes:
measure: Change in Dyspnea at VO2max
timeFrame: Change between Day 0 and Day 90 +- 30
Secondary outcomes:
measure: Time to start of mouth-breathing during exercise test
timeFrame: Change between Day 0 and Day 90 +- 30
measure: The SNOT22 questionnaire score
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Ventilation during isowork
timeFrame: Change between Day 0 and Day 90 +- 30
measure: PACO2 at rest
timeFrame: Change between Day 0 and Day 90 +- 30
measure: pH at rest
timeFrame: Change between Day 0 and Day 90 +- 30
measure: PaO2 at rest
timeFrame: Change between Day 0 and Day 90 +- 30
measure: PACO2 at maximum effort
timeFrame: Change between Day 0 and Day 90 +- 30
measure: pH at maximum effort
timeFrame: Change between Day 0 and Day 90 +- 30
measure: PaO2 at maximum effort
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Breathing rates during excerise testing
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Transcutaneous oximetry
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Distance walked during 6 minute walking test
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Maximum rate of oxygen consumption
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Maximum dyspnea values
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Dyspnea threshold during exercise testing
timeFrame: Change between Day 0 and Day 90 +- 30
measure: The slope of the equation VE=f(PETCO2)
timeFrame: Change between Day 0 and Day 90 +- 30
measure: PETCO2 value when VE = 0
timeFrame: Change between Day 0 and Day 90 +- 30
measure: the equation P0.1=f(PETCO2)
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Dyspnea measured using the MRC scale
timeFrame: Change between Day 0 and Day 90 +- 30
measure: Nijmegen questionnaire score
timeFrame: Change between Day 0 and Day 90 +- 30
measure: SF36 questionnaire score
timeFrame: Change between Day 0 and Day 90 +- 30
measure: VQ-11 questionnaire score
timeFrame: Change between Day 0 and Day 90 +- 30
measure: HAD questionnaire score
timeFrame: Change between Day 0 and Day 90 +- 30
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Florence Pourias Laborde, DE
role: STUDY_DIRECTOR
References: