Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Mechanical Ventilation
  • Neuromuscular Diseases
  • Speech
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: monocentric, open, randomized, crossover studyMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Nowadays, the first line treatment of chronic respiratory failure in neuromuscular disorder is non invasive ventilation (NIV). However, while NIV can compensate the respiratory disability and significantly delays significantly the necessity for invasive ventilation with a tracheostomy (IVT), it is u...

Nowadays, the first line treatment of chronic respiratory failure in neuromuscular disorder is non invasive ventilation (NIV). However, while NIV can compensate the respiratory disability and significantly delays significantly the necessity for invasive ventilation with a tracheostomy (IVT), it is used for significant periods of time during daytime in patients with severe respiratory failure and can therefore interfere with patients' speech. Moreover, if NIV becomes inefficient, IVT may be required to pursue ventilatory support to treat the respiratory failure; tracheostomy also interferes with phonation and specific adaptations are necessary to optimize phonation and speech quality. Adaptation of ventilation parameters (mainly triggering sensitivity and use of positive expiratory pressure (PEP)) can significantly improve speech quality and therefore ventilated patients' communication. These adapted parameters are not strictly necessary for ventilation outside of speaking periods. It would be of interest to be able to use them exclusively during speech. In neuromuscular patients, the major motor disability constitutes a challenge as most patients are unable to use themselves the controls of their ventilator (and to potentially switch to a speech adapted ventilation program). We want to evaluate a device able to automatically detect speech and to transitorily switch from the patient's usual ventilation parameters to speech specific parameters set to optimize phonation quality. Specific adaptations differs between NIV or IVT, therefore we will evaluation two groups of ventilation dependent patients divided according to their ventilation mode. We believe that this device may improve the speech of NIV patients as well as IVT patients. Patients would benefit from an appropriate ventilator support without any ventilation desynchronization during speech. Speech would be more fluent and natural which would result in improved communication. Objectives The main objective of this study is to demonstrate that phonation is improved by the use of a device allowing the transitory switch to specific speech parameters of ventilation in neuromuscular ventilator dependent patient whether during NIV or during IMT.

Tracking Information

NCT #
NCT03504514
Collaborators
Not Provided
Investigators
Principal Investigator: Hélène Prigent, MD PhD Raymond Poincaré Hospital