Clinical Trial: Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University Hospital, Montpellier

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: May 16, 2017
Date Started: May 30, 2017
Date Completion: March 30, 2019
Last Updated: May 16, 2017
Last Verified: May 2017