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 ]
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