Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome

Hyperventilation Syndrome Clinical Trial

— RehabSHV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03159429
• Other study ID #: 9796
• Secondary ID: 2017-A00554-49
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hyperventilation
• Hyperventilation Syndrome
• Hypoventilation
• Syndrome

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	APARD Fonds de dotation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The SNOT22 questionnaire score	The SNOT22 questionnaire score	Change between Day 0 and Day 90 +- 30
Secondary	Ventilation during isowork	(Ventilation equivalents V'E / V'O2 and V'E / V'CO2)	Change between Day 0 and Day 90 +- 30
Secondary	PACO2 at rest	PAC02 = Partial pressure of carbon dioxide in arterial blood	Change between Day 0 and Day 90 +- 30
Secondary	pH at rest	pH at rest	Change between Day 0 and Day 90 +- 30
Secondary	PaO2 at rest	PaO2 = Partial pressure of oxygen in arterial blood	Change between Day 0 and Day 90 +- 30
Secondary	PACO2 at maximum effort	PAC02 = Partial pressure of carbon dioxide in arterial blood	Change between Day 0 and Day 90 +- 30
Secondary	pH at maximum effort	pH at maximum effort	Change between Day 0 and Day 90 +- 30
Secondary	PaO2 at maximum effort	PaO2 = Partial pressure of oxygen in arterial blood	Change between Day 0 and Day 90 +- 30
Secondary	Breathing rates during excerise testing	breaths per minute	Change between Day 0 and Day 90 +- 30
Secondary	Transcutaneous oximetry	tcpO2	Change between Day 0 and Day 90 +- 30
Secondary	Distance walked during 6 minute walking test	Distance walked during 6 minute walking test	Change between Day 0 and Day 90 +- 30
Secondary	Maximum rate of oxygen consumption	VO2max	Change between Day 0 and Day 90 +- 30
Secondary	Maximum dyspnea values	Dyspnea is measured using visual analogue scales	Change between Day 0 and Day 90 +- 30
Secondary	Dyspnea threshold during exercise testing	Dyspnea is measured using visual analogue scales	Change between Day 0 and Day 90 +- 30
Secondary	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
Secondary	PETCO2 value when VE = 0	VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension	Change between Day 0 and Day 90 +- 30
Secondary	the equation P0.1=f(PETCO2)	P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension	Change between Day 0 and Day 90 +- 30
Secondary	Dyspnea measured using the MRC scale	Dyspnea measured using the Medical Research Council scale	Change between Day 0 and Day 90 +- 30
Secondary	Nijmegen questionnaire score	Nijmegen questionnaire score	Change between Day 0 and Day 90 +- 30
Secondary	SF36 questionnaire score	SF36 questionnaire score	Change between Day 0 and Day 90 +- 30
Secondary	VQ-11 questionnaire score	VQ-11 questionnaire score	Change between Day 0 and Day 90 +- 30
Secondary	HAD questionnaire score	HAD questionnaire score	Change between Day 0 and Day 90 +- 30