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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00554-49 | Other Identifier | RCB number |
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| Name | Class |
|---|---|
| APARD Fonds de dotation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patients randomized to this arm will participate in the new rehabilitation programme. Intervention: Nasal breathing rehabilitation |
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| Comparator arm | Active Comparator | Patients randomized to this arm will participate in the usual rehabilitation programme. Intervention: Standard rehabilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dyspnea at VO2max | Dyspnea measured at the first VO2max during a maximal cardio-pulmonary effort test. Dyspnea is measured using a visual analog scale. | Change between Day 0 and Day 90 +- 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to start of mouth-breathing during exercise test | The delay of onset of oral ventilation during walking and / or on ergocycle | Change between Day 0 and Day 90 +- 30 |
| The SNOT22 questionnaire score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Pourias Laborde, DE | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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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.
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Given that the experimental and comparator interventions concern behaviour and exercises, it is not possible to blind participants.
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| Nasal breathing rehabilitation | Behavioral | 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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The SNOT22 questionnaire score
| Change between Day 0 and Day 90 +- 30 |
| Ventilation during isowork | (Ventilation equivalents V'E / V'O2 and V'E / V'CO2) | Change between Day 0 and Day 90 +- 30 |
| PACO2 at rest | PAC02 = Partial pressure of carbon dioxide in arterial blood | Change between Day 0 and Day 90 +- 30 |
| pH at rest | pH at rest | Change between Day 0 and Day 90 +- 30 |
| PaO2 at rest | PaO2 = Partial pressure of oxygen in arterial blood | Change between Day 0 and Day 90 +- 30 |
| PACO2 at maximum effort | PAC02 = Partial pressure of carbon dioxide in arterial blood | Change between Day 0 and Day 90 +- 30 |
| pH at maximum effort | pH at maximum effort | Change between Day 0 and Day 90 +- 30 |
| PaO2 at maximum effort | PaO2 = Partial pressure of oxygen in arterial blood | Change between Day 0 and Day 90 +- 30 |
| Breathing rates during excerise testing | breaths per minute | Change between Day 0 and Day 90 +- 30 |
| Transcutaneous oximetry | tcpO2 | Change between Day 0 and Day 90 +- 30 |
| Distance walked during 6 minute walking test | Distance walked during 6 minute walking test | Change between Day 0 and Day 90 +- 30 |
| Maximum rate of oxygen consumption | VO2max | Change between Day 0 and Day 90 +- 30 |
| Maximum dyspnea values | Dyspnea is measured using visual analogue scales | Change between Day 0 and Day 90 +- 30 |
| Dyspnea threshold during exercise testing | Dyspnea is measured using visual analogue scales | Change between Day 0 and Day 90 +- 30 |
| The slope of the equation VE=f(PETCO2) | VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension | Change between Day 0 and Day 90 +- 30 |
| PETCO2 value when VE = 0 | VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension | Change between Day 0 and Day 90 +- 30 |
| the equation P0.1=f(PETCO2) | P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension | Change between Day 0 and Day 90 +- 30 |
| Dyspnea measured using the MRC scale | Dyspnea measured using the Medical Research Council scale | Change between Day 0 and Day 90 +- 30 |
| Nijmegen questionnaire score | Nijmegen questionnaire score | Change between Day 0 and Day 90 +- 30 |
| SF36 questionnaire score | SF36 questionnaire score | Change between Day 0 and Day 90 +- 30 |
| VQ-11 questionnaire score | VQ-11 questionnaire score | Change between Day 0 and Day 90 +- 30 |
| HAD questionnaire score | HAD questionnaire score | Change between Day 0 and Day 90 +- 30 |
| D013568 | Pathological Conditions, Signs and Symptoms |