Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation (Ventiphono)
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|ClinicalTrials.gov Identifier: NCT03504514|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Diseases Mechanical Ventilation Speech||Device: speech trials during different ventilation conditions Other: speech trial||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||monocentric, open, randomized, crossover study|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation|
|Actual Study Start Date :||November 6, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
No Intervention: Conventional mechanical ventilation
Conventional mechanical ventilation, with patient ventilator usual parameters
Experimental: Adapted mechanical ventilation
Mechanical ventilation with parameters specifically modified to improve speech the effect is evaluated with speech trials during different ventilation conditions
Device: speech trials during different ventilation conditions
ventilator parameters are modified
Other: speech trial
reading duration, vocal flow, intelligibility and voice quality will be evaluated during speech
- reading duration [ Time Frame: 15 minutes ]duration for reading a specific text in seconds
- Vocal flow [ Time Frame: 15 minutes ]vocal flow in syllables/second during the reading of a specific text
- vocal range [ Time Frame: 2 minutes ]vocal range from lowest to highest pitch
- intelligibility [ Time Frame: 15 minutes ]evaluation of intelligibility during reading evaluated by listeners blinded to ventilation conditions
- Speech quality [ Time Frame: 5 min ]evaluation of prosodia by listeners blinded to ventilation conditions
- Speech quality [ Time Frame: 1 minute ]evaluation of speech quality by the patient using a visual analogical scale
- Speech comfort [ Time Frame: 1 minute ]evaluation of speech comfort by the patient using a visual analogical scale
- Respiratory comfort [ Time Frame: 1 minute ]evaluation of respiratory comfort by the patient using a visual analogical scale
- dyspnea [ Time Frame: 1 minute ]evaluation of dyspnea during speech evaluated with the modified Borg scale (ranking from 0 to10)
- oxygen saturation [ Time Frame: 15 min ]evaluation of Respiratory tolerance during speech by measuring oxygen saturation
- respiratory rate [ Time Frame: 15 min ]evaluation of Respiratory tolerance during speech by measuring respiratory rate
- cardiac frequency [ Time Frame: 15 min ]evaluation of Cardiovascular tolerance during speech by measuring cardiac frequency
- Patient satisfaction [ Time Frame: 1 minute ]evaluation of Patient satisfaction with speech with the ventilation mode by the patient using a visual analogical scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504514
|Contact: Hélène Prigent, MD PhDemail@example.com|
|Contact: Isabelle BOSSARDfirstname.lastname@example.org|
|Principal Investigator:||Hélène Prigent, MD PhD||Raymond Poincaré Hospital|