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

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.

Study Overview

• Status: Terminated
• Conditions: Hyperventilation Syndrome
• Intervention / Treatment: Behavioral: Nasal breathing rehabilitation; Behavioral: Standard rehabilitation

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: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; Patients randomized to this arm will participate in the new rehabilitation programme. Intervention: Nasal breathing rehabilitation	Behavioral: 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.
Active Comparator: Comparator arm; Patients randomized to this arm will participate in the usual rehabilitation programme. Intervention: Standard rehabilitation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: APARD Fonds de dotation
• Investigators: Study Director: Florence Pourias Laborde, DE, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Dyspnea; Hyperventilation syndrome; Rehabilitation of olfaction
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Syndrome; Hypoventilation; Hyperventilation
• 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: No
• Studies a U.S. FDA-regulated device product: No