Back to resultsNasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome (RehabSHV)
Primary Purpose
Hyperventilation Syndrome
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard rehabilitation
Nasal breathing rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Hyperventilation Syndrome focused on measuring Dyspnea, Rehabilitation of olfaction, Hyperventilation syndrome
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)
Sites / Locations
- Montpellier University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental arm
Comparator arm
Arm Description
Patients randomized to this arm will participate in the new rehabilitation programme. Intervention: Nasal breathing rehabilitation
Patients randomized to this arm will participate in the usual rehabilitation programme. Intervention: Standard rehabilitation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to start of mouth-breathing during exercise test
The delay of onset of oral ventilation during walking and / or on ergocycle
The SNOT22 questionnaire score
The SNOT22 questionnaire score
Ventilation during isowork
(Ventilation equivalents V'E / V'O2 and V'E / V'CO2)
PACO2 at rest
PAC02 = Partial pressure of carbon dioxide in arterial blood
pH at rest
pH at rest
PaO2 at rest
PaO2 = Partial pressure of oxygen in arterial blood
PACO2 at maximum effort
PAC02 = Partial pressure of carbon dioxide in arterial blood
pH at maximum effort
pH at maximum effort
PaO2 at maximum effort
PaO2 = Partial pressure of oxygen in arterial blood
Breathing rates during excerise testing
breaths per minute
Transcutaneous oximetry
tcpO2
Distance walked during 6 minute walking test
Distance walked during 6 minute walking test
Maximum rate of oxygen consumption
VO2max
Maximum dyspnea values
Dyspnea is measured using visual analogue scales
Dyspnea threshold during exercise testing
Dyspnea is measured using visual analogue scales
The slope of the equation VE=f(PETCO2)
VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
PETCO2 value when VE = 0
VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
the equation P0.1=f(PETCO2)
P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension
Dyspnea measured using the MRC scale
Dyspnea measured using the Medical Research Council scale
Nijmegen questionnaire score
Nijmegen questionnaire score
SF36 questionnaire score
SF36 questionnaire score
VQ-11 questionnaire score
VQ-11 questionnaire score
HAD questionnaire score
HAD questionnaire score
Full Information
NCT ID
NCT03159429
First Posted
May 16, 2017
Last Updated
April 8, 2020
Sponsor
University Hospital, Montpellier
Collaborators
APARD Fonds de dotation
1. Study Identification
Unique Protocol Identification Number
NCT03159429
Brief Title
Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome
Acronym
RehabSHV
Official Title
Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Staff no longer available.
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
APARD Fonds de dotation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperventilation Syndrome
Keywords
Dyspnea, Rehabilitation of olfaction, Hyperventilation syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Given that the experimental and comparator interventions concern behaviour and exercises, it is not possible to blind participants.
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Patients randomized to this arm will participate in the new rehabilitation programme.
Intervention: Nasal breathing rehabilitation
Arm Title
Comparator arm
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will participate in the usual rehabilitation programme.
Intervention: Standard rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Standard rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nasal breathing rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Dyspnea at VO2max
Description
Dyspnea measured at the first VO2max during a maximal cardio-pulmonary effort test. Dyspnea is measured using a visual analog scale.
Time Frame
Change between Day 0 and Day 90 +- 30
Secondary Outcome Measure Information:
Title
Time to start of mouth-breathing during exercise test
Description
The delay of onset of oral ventilation during walking and / or on ergocycle
Time Frame
Change between Day 0 and Day 90 +- 30
Title
The SNOT22 questionnaire score
Description
The SNOT22 questionnaire score
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Ventilation during isowork
Description
(Ventilation equivalents V'E / V'O2 and V'E / V'CO2)
Time Frame
Change between Day 0 and Day 90 +- 30
Title
PACO2 at rest
Description
PAC02 = Partial pressure of carbon dioxide in arterial blood
Time Frame
Change between Day 0 and Day 90 +- 30
Title
pH at rest
Description
pH at rest
Time Frame
Change between Day 0 and Day 90 +- 30
Title
PaO2 at rest
Description
PaO2 = Partial pressure of oxygen in arterial blood
Time Frame
Change between Day 0 and Day 90 +- 30
Title
PACO2 at maximum effort
Description
PAC02 = Partial pressure of carbon dioxide in arterial blood
Time Frame
Change between Day 0 and Day 90 +- 30
Title
pH at maximum effort
Description
pH at maximum effort
Time Frame
Change between Day 0 and Day 90 +- 30
Title
PaO2 at maximum effort
Description
PaO2 = Partial pressure of oxygen in arterial blood
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Breathing rates during excerise testing
Description
breaths per minute
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Transcutaneous oximetry
Description
tcpO2
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Distance walked during 6 minute walking test
Description
Distance walked during 6 minute walking test
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Maximum rate of oxygen consumption
Description
VO2max
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Maximum dyspnea values
Description
Dyspnea is measured using visual analogue scales
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Dyspnea threshold during exercise testing
Description
Dyspnea is measured using visual analogue scales
Time Frame
Change between Day 0 and Day 90 +- 30
Title
The slope of the equation VE=f(PETCO2)
Description
VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
Time Frame
Change between Day 0 and Day 90 +- 30
Title
PETCO2 value when VE = 0
Description
VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
Time Frame
Change between Day 0 and Day 90 +- 30
Title
the equation P0.1=f(PETCO2)
Description
P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Dyspnea measured using the MRC scale
Description
Dyspnea measured using the Medical Research Council scale
Time Frame
Change between Day 0 and Day 90 +- 30
Title
Nijmegen questionnaire score
Description
Nijmegen questionnaire score
Time Frame
Change between Day 0 and Day 90 +- 30
Title
SF36 questionnaire score
Description
SF36 questionnaire score
Time Frame
Change between Day 0 and Day 90 +- 30
Title
VQ-11 questionnaire score
Description
VQ-11 questionnaire score
Time Frame
Change between Day 0 and Day 90 +- 30
Title
HAD questionnaire score
Description
HAD questionnaire score
Time Frame
Change between Day 0 and Day 90 +- 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Pourias Laborde, DE
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome
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