Hyperventilation SyndromeRehabSHVNCT03159429
Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome
A study testing Standard rehabilitation and Nasal breathing rehabilitation in people with Hyperventilation Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperventilation Syndrome
- What is being tested?
- Standard rehabilitation and Nasal breathing rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2017to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Hyperventilation Syndrome
- Being tested
- Standard rehabilitation, Nasal breathing rehabilitation
- Keywords
- Dyspnea, Rehabilitation of olfaction, Hyperventilation syndrome
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitationBehavioural
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.
Nasal breathing rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients randomized to this arm will participate in the new rehabilitation programme.
Intervention: Nasal breathing rehabilitation Receives: Behavioral: Nasal breathing rehabilitation |
| Comparator arm | Active comparator | Patients randomized to this arm will participate in the usual rehabilitation programme.
Intervention: Standard rehabilitation Receives: Behavioral: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between Day 0 and Day 90 +- 30
Secondary outcomes (23)
Time to start of mouth-breathing during exercise test
The delay of onset of oral ventilation during walking and / or on ergocycle
Measured: Change between Day 0 and Day 90 +- 30
The SNOT22 questionnaire score
The SNOT22 questionnaire score
Measured: Change between Day 0 and Day 90 +- 30
Ventilation during isowork
(Ventilation equivalents V'E / V'O2 and V'E / V'CO2)
Measured: Change between Day 0 and Day 90 +- 30
PACO2 at rest
PAC02 = Partial pressure of carbon dioxide in arterial blood
Measured: Change between Day 0 and Day 90 +- 30
pH at rest
pH at rest
Measured: Change between Day 0 and Day 90 +- 30
PaO2 at rest
PaO2 = Partial pressure of oxygen in arterial blood
Measured: Change between Day 0 and Day 90 +- 30
PACO2 at maximum effort
PAC02 = Partial pressure of carbon dioxide in arterial blood
Measured: Change between Day 0 and Day 90 +- 30
pH at maximum effort
pH at maximum effort
Measured: Change between Day 0 and Day 90 +- 30
PaO2 at maximum effort
PaO2 = Partial pressure of oxygen in arterial blood
Measured: Change between Day 0 and Day 90 +- 30
Breathing rates during excerise testing
breaths per minute
Measured: Change between Day 0 and Day 90 +- 30
Transcutaneous oximetry
tcpO2
Measured: Change between Day 0 and Day 90 +- 30
Distance walked during 6 minute walking test
Distance walked during 6 minute walking test
Measured: Change between Day 0 and Day 90 +- 30
Maximum rate of oxygen consumption
VO2max
Measured: Change between Day 0 and Day 90 +- 30
Maximum dyspnea values
Dyspnea is measured using visual analogue scales
Measured: Change between Day 0 and Day 90 +- 30
Dyspnea threshold during exercise testing
Dyspnea is measured using visual analogue scales
Measured: 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
Measured: Change between Day 0 and Day 90 +- 30
PETCO2 value when VE = 0
VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension
Measured: Change between Day 0 and Day 90 +- 30
the equation P0.1=f(PETCO2)
P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension
Measured: Change between Day 0 and Day 90 +- 30
Dyspnea measured using the MRC scale
Dyspnea measured using the Medical Research Council scale
Measured: Change between Day 0 and Day 90 +- 30
Nijmegen questionnaire score
Nijmegen questionnaire score
Measured: Change between Day 0 and Day 90 +- 30
SF36 questionnaire score
SF36 questionnaire score
Measured: Change between Day 0 and Day 90 +- 30
VQ-11 questionnaire score
VQ-11 questionnaire score
Measured: Change between Day 0 and Day 90 +- 30
HAD questionnaire score
HAD questionnaire score
Measured: Change between Day 0 and Day 90 +- 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start5 Oct 2017
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Why it stopped: Staff no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperventilation SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- APARD Fonds de dotation
- Responsible party
- Sponsor
- Investigators
- Florence Pourias Laborde, DE, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159429
- Sponsor's protocol ID
- 9796
- Other IDs
- 2017-A00554-49
- Acronym
- RehabSHV
- Status last verified
- Apr 2020
- First submitted
- 16 May 2017
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03159429
- Acronym / sponsor ID
- RehabSHV / 9796
- Conditions
- Hyperventilation Syndrome
- Keywords
- Dyspnea, Rehabilitation of olfaction, Hyperventilation syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staff no longer available.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- APARD Fonds de dotation
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: Nasal breathing rehabilitationPatients randomized to this arm will participate in the new rehabilitation programme. Intervention: Nasal breathing rehabilitation |
| Comparator arm | Active comparator | Behavioral: Standard rehabilitationPatients randomized to this arm will participate in the usual rehabilitation programme. Intervention: Standard rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard rehabilitationThe 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. | Behavioural | Comparator arm |
| Nasal breathing rehabilitationThe 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. | Behavioural | Experimental arm |
Primary outcome
Change in Dyspnea at VO2max
Time frame: Change between Day 0 and Day 90 +- 30
Dyspnea measured at the first VO2max during a maximal cardio-pulmonary effort test. Dyspnea is measured using a visual analog scale.
23 secondary outcomes
Time to start of mouth-breathing during exercise test
Time frame: Change between Day 0 and Day 90 +- 30
The SNOT22 questionnaire score
Time frame: Change between Day 0 and Day 90 +- 30
Ventilation during isowork
Time frame: Change between Day 0 and Day 90 +- 30
PACO2 at rest
Time frame: Change between Day 0 and Day 90 +- 30
pH at rest
Time frame: Change between Day 0 and Day 90 +- 30
PaO2 at rest
Time frame: Change between Day 0 and Day 90 +- 30
PACO2 at maximum effort
Time frame: Change between Day 0 and Day 90 +- 30
pH at maximum effort
Time frame: Change between Day 0 and Day 90 +- 30
PaO2 at maximum effort
Time frame: Change between Day 0 and Day 90 +- 30
Breathing rates during excerise testing
Time frame: Change between Day 0 and Day 90 +- 30
Transcutaneous oximetry
Time frame: Change between Day 0 and Day 90 +- 30
Distance walked during 6 minute walking test
Time frame: Change between Day 0 and Day 90 +- 30
Maximum rate of oxygen consumption
Time frame: Change between Day 0 and Day 90 +- 30
Maximum dyspnea values
Time frame: Change between Day 0 and Day 90 +- 30
Dyspnea threshold during exercise testing
Time frame: Change between Day 0 and Day 90 +- 30
The slope of the equation VE=f(PETCO2)
Time frame: Change between Day 0 and Day 90 +- 30
PETCO2 value when VE = 0
Time frame: Change between Day 0 and Day 90 +- 30
the equation P0.1=f(PETCO2)
Time frame: Change between Day 0 and Day 90 +- 30
Dyspnea measured using the MRC scale
Time frame: Change between Day 0 and Day 90 +- 30
Nijmegen questionnaire score
Time frame: Change between Day 0 and Day 90 +- 30
SF36 questionnaire score
Time frame: Change between Day 0 and Day 90 +- 30
VQ-11 questionnaire score
Time frame: Change between Day 0 and Day 90 +- 30
HAD questionnaire score
Time frame: Change between Day 0 and Day 90 +- 30
Results and safety
The study was stopped early (reason given: Staff no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Pourias Laborde, DE study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehabilitation and Nasal breathing rehabilitation in people with Hyperventilation Syndrome, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Staff no longer available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dyspnea at VO2max (time frame: Change between Day 0 and Day 90 +- 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.