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Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome

Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03159429
Acronym
RehabSHV
Enrollment
19
Registered
2017-05-18
Start date
2017-10-05
Completion date
2020-01-15
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperventilation Syndrome

Keywords

Dyspnea, Rehabilitation of olfaction, Hyperventilation syndrome

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.

Interventions

BEHAVIORALStandard rehabilitation

The patient will participate in a therapeutic education programme consisting of 4 visits (days 1 +- 14, 21 +- 14, 61 +- 14 and 90 +-14) representing usual procedures, which include: maintaining a diary, breathing coordination excercises, voluntary control of breathing rate, releasing contracted muscles, posture harmonization, a six minute walking test, and walking up four flights of stairs.

BEHAVIORALNasal breathing rehabilitation

The patient will participate in a therapeutic education programme consisting of 4 visits (days 1 +- 14, 21 +- 14, 61 +- 14 and 90 +-14) representing the experimental procedures, which include: maintaining a diary, evaluating nasal breathing by the nostril-alternating technique according to Anuloma Viloma Pranayama Yoga, releasing contracted muscles, posture harmonization, a six minute walking test, and walking up four flights of stairs.

Sponsors

APARD Fonds de dotation
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Given that the experimental and comparator interventions concern behaviour and exercises, it is not possible to blind participants.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Dyspnea at VO2maxChange between Day 0 and Day 90 +- 30Dyspnea measured at the first VO2max during a maximal cardio-pulmonary effort test. Dyspnea is measured using a visual analog scale.

Secondary

MeasureTime frameDescription
Time to start of mouth-breathing during exercise testChange between Day 0 and Day 90 +- 30The delay of onset of oral ventilation during walking and / or on ergocycle
The SNOT22 questionnaire scoreChange between Day 0 and Day 90 +- 30The SNOT22 questionnaire score
Ventilation during isoworkChange between Day 0 and Day 90 +- 30(Ventilation equivalents V'E / V'O2 and V'E / V'CO2)
PACO2 at restChange between Day 0 and Day 90 +- 30PAC02 = Partial pressure of carbon dioxide in arterial blood
pH at restChange between Day 0 and Day 90 +- 30pH at rest
PaO2 at restChange between Day 0 and Day 90 +- 30PaO2 = Partial pressure of oxygen in arterial blood
PACO2 at maximum effortChange between Day 0 and Day 90 +- 30PAC02 = Partial pressure of carbon dioxide in arterial blood
pH at maximum effortChange between Day 0 and Day 90 +- 30pH at maximum effort
PaO2 at maximum effortChange between Day 0 and Day 90 +- 30PaO2 = Partial pressure of oxygen in arterial blood
Breathing rates during excerise testingChange between Day 0 and Day 90 +- 30breaths per minute
Transcutaneous oximetryChange between Day 0 and Day 90 +- 30tcpO2
Maximum dyspnea valuesChange between Day 0 and Day 90 +- 30Dyspnea is measured using visual analogue scales
Maximum rate of oxygen consumptionChange between Day 0 and Day 90 +- 30VO2max
Dyspnea threshold during exercise testingChange between Day 0 and Day 90 +- 30Dyspnea is measured using visual analogue scales
The slope of the equation VE=f(PETCO2)Change between Day 0 and Day 90 +- 30VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
PETCO2 value when VE = 0Change between Day 0 and Day 90 +- 30VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
the equation P0.1=f(PETCO2)Change between Day 0 and Day 90 +- 30P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension
Dyspnea measured using the MRC scaleChange between Day 0 and Day 90 +- 30Dyspnea measured using the Medical Research Council scale
Nijmegen questionnaire scoreChange between Day 0 and Day 90 +- 30Nijmegen questionnaire score
SF36 questionnaire scoreChange between Day 0 and Day 90 +- 30SF36 questionnaire score
VQ-11 questionnaire scoreChange between Day 0 and Day 90 +- 30VQ-11 questionnaire score
HAD questionnaire scoreChange between Day 0 and Day 90 +- 30HAD questionnaire score
Distance walked during 6 minute walking testChange between Day 0 and Day 90 +- 30Distance walked during 6 minute walking test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026