Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome

NCT03159429 | Terminated

• 2 other identifiers: 97962017-A00554-49
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperventilation Syndrome

Keywords

Dyspnea; Rehabilitation of olfaction; Hyperventilation syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Time to start of mouth-breathing during exercise test

  Change between Day 0 and Day 90 +- 30

• The SNOT22 questionnaire score

  Change between Day 0 and Day 90 +- 30

• Ventilation during isowork

  Change between Day 0 and Day 90 +- 30

• PACO2 at rest

  Change between Day 0 and Day 90 +- 30

• pH at rest

  Change between Day 0 and Day 90 +- 30

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients randomized to this arm will participate in the new rehabilitation programme. Intervention: Nasal breathing rehabilitation

Behavioral: Nasal breathing rehabilitation

Comparator arm

ACTIVE COMPARATOR

Patients randomized to this arm will participate in the usual rehabilitation programme. Intervention: Standard rehabilitation

Behavioral: Standard rehabilitation

Interventions

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.

Comparator arm

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The subject is participating in another 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• APARD Fonds de dotation: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Florence Pourias Laborde, DE

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given that the experimental and comparator interventions concern behaviour and exercises, it is not possible to blind participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: October 5, 2017
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

FR (1)