- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03159429
Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome (RehabSHV)
Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Montpellier University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental arm
Patients randomized to this arm will participate in the new rehabilitation programme. Intervention: Nasal 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.
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Active Comparator: Comparator arm
Patients randomized to this arm will participate in the usual rehabilitation programme. Intervention: Standard 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Dyspnea at VO2max
Time Frame: Change between Day 0 and Day 90 +- 30
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Dyspnea measured at the first VO2max during a maximal cardio-pulmonary effort test.
Dyspnea is measured using a visual analog scale.
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Change between Day 0 and Day 90 +- 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to start of mouth-breathing during exercise test
Time Frame: Change between Day 0 and Day 90 +- 30
|
The delay of onset of oral ventilation during walking and / or on ergocycle
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Change between Day 0 and Day 90 +- 30
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The SNOT22 questionnaire score
Time Frame: Change between Day 0 and Day 90 +- 30
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The SNOT22 questionnaire score
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Change between Day 0 and Day 90 +- 30
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Ventilation during isowork
Time Frame: Change between Day 0 and Day 90 +- 30
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(Ventilation equivalents V'E / V'O2 and V'E / V'CO2)
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Change between Day 0 and Day 90 +- 30
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PACO2 at rest
Time Frame: Change between Day 0 and Day 90 +- 30
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PAC02 = Partial pressure of carbon dioxide in arterial blood
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Change between Day 0 and Day 90 +- 30
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pH at rest
Time Frame: Change between Day 0 and Day 90 +- 30
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pH at rest
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Change between Day 0 and Day 90 +- 30
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PaO2 at rest
Time Frame: Change between Day 0 and Day 90 +- 30
|
PaO2 = Partial pressure of oxygen in arterial blood
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Change between Day 0 and Day 90 +- 30
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PACO2 at maximum effort
Time Frame: Change between Day 0 and Day 90 +- 30
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PAC02 = Partial pressure of carbon dioxide in arterial blood
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Change between Day 0 and Day 90 +- 30
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pH at maximum effort
Time Frame: Change between Day 0 and Day 90 +- 30
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pH at maximum effort
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Change between Day 0 and Day 90 +- 30
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PaO2 at maximum effort
Time Frame: Change between Day 0 and Day 90 +- 30
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PaO2 = Partial pressure of oxygen in arterial blood
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Change between Day 0 and Day 90 +- 30
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Breathing rates during excerise testing
Time Frame: Change between Day 0 and Day 90 +- 30
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breaths per minute
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Change between Day 0 and Day 90 +- 30
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Transcutaneous oximetry
Time Frame: Change between Day 0 and Day 90 +- 30
|
tcpO2
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Change between Day 0 and Day 90 +- 30
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Distance walked during 6 minute walking test
Time Frame: Change between Day 0 and Day 90 +- 30
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Distance walked during 6 minute walking test
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Change between Day 0 and Day 90 +- 30
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Maximum rate of oxygen consumption
Time Frame: Change between Day 0 and Day 90 +- 30
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VO2max
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Change between Day 0 and Day 90 +- 30
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Maximum dyspnea values
Time Frame: Change between Day 0 and Day 90 +- 30
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Dyspnea is measured using visual analogue scales
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Change between Day 0 and Day 90 +- 30
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Dyspnea threshold during exercise testing
Time Frame: Change between Day 0 and Day 90 +- 30
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Dyspnea is measured using visual analogue scales
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Change between Day 0 and Day 90 +- 30
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The slope of the equation VE=f(PETCO2)
Time Frame: Change between Day 0 and Day 90 +- 30
|
VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
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Change between Day 0 and Day 90 +- 30
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PETCO2 value when VE = 0
Time Frame: Change between Day 0 and Day 90 +- 30
|
VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
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Change between Day 0 and Day 90 +- 30
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the equation P0.1=f(PETCO2)
Time Frame: Change between Day 0 and Day 90 +- 30
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P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension
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Change between Day 0 and Day 90 +- 30
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Dyspnea measured using the MRC scale
Time Frame: Change between Day 0 and Day 90 +- 30
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Dyspnea measured using the Medical Research Council scale
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Change between Day 0 and Day 90 +- 30
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Nijmegen questionnaire score
Time Frame: Change between Day 0 and Day 90 +- 30
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Nijmegen questionnaire score
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Change between Day 0 and Day 90 +- 30
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SF36 questionnaire score
Time Frame: Change between Day 0 and Day 90 +- 30
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SF36 questionnaire score
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Change between Day 0 and Day 90 +- 30
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VQ-11 questionnaire score
Time Frame: Change between Day 0 and Day 90 +- 30
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VQ-11 questionnaire score
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Change between Day 0 and Day 90 +- 30
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HAD questionnaire score
Time Frame: Change between Day 0 and Day 90 +- 30
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HAD questionnaire score
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Change between Day 0 and Day 90 +- 30
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Florence Pourias Laborde, DE, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9796
- 2017-A00554-49 (Other Identifier: RCB number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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