Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation (Ventiphono)

Ventilation is a major treatment of respiratory failure due to neuromuscular disorders. First line treatment is noninvasive ventilation (NIV) but in some situations, especially in case of NIV inefficiency, invasive ventilation with tracheostomy (IVT) may be required. In both situations, patients may become dependent on ventilatory support with the disease evolution. Ventilation then can interfere speech and the quality of communication of the patients. Modification of the ventilation parameters may result in improved speech quality (for example, positive expiratory pressure (PEP) while not necessary for ventilation quality can dramatically improve speech in tracheostomized patients). Therefore, it would be of interest to allow patients to benefit from these specific parameters when they need to speak without maintaining them when patients are not speaking. We want to evaluate a specific ventilator feature which can detect speech and switch to specific ventilation parameters adapted for speech We believe that this feature will improve significantly speech quality in patients dependant either on NIV or IVT.

Study Overview

• Status: Unknown
• Conditions: Neuromuscular Diseases; Mechanical Ventilation; Speech
• Intervention / Treatment: Device: speech trials during different ventilation conditions; Other: speech trial

Detailed 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 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
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène PRIGENT, MD PhD; Phone Number: 0033147107911; Email: helene.prigent@aphp.fr
• Study Contact Backup: Name: Isabelle BOSSARD; Phone Number: 0033147104615; Email: isabelle.bossard@aphp.fr

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Raymond Poincaré Hospital
    • Contact: Hélène PRIGENT, MD PhD; Phone Number: 0033147107911; Email: helene.prigent@aphp.fr
    • Principal Investigator: Hélène PRIGENT, MD PhD
    • Contact: Isabelle BOSSARD; Phone Number: 0033147104615; Email: isabelle.bossard@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients (age > or equal to 18)
• Neuromuscular patients with a restrictive respiratory failure without major bulbar involvement.
• Adult patient.
• Ventilator dependancy= ventilation duration of 16h/day or more either with NIV or IMT
• Leak ventilation for IMT patients
• Respiratory autonomy of at leat 1h per day
• Usual ventilation mode : assist control mode (either pressure or volume controlled mode) ou spontaneous breathing mode with target volume
• Stable hemodynamic state
• Signed informed consent

Exclusion Criteria:

• Refusal to participate
• Use of cuffed tracheostomy tube
• Inability to read
• Pregnancy
• Protected adults
• Acute respiratory failure
• Hemodynamic instability
• not registered with the social security system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reading duration	duration for reading a specific text in seconds	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vocal flow	vocal flow in syllables/second during the reading of a specific text	15 minutes
vocal range	vocal range from lowest to highest pitch	2 minutes
intelligibility	evaluation of intelligibility during reading evaluated by listeners blinded to ventilation conditions	15 minutes
Speech quality	evaluation of prosodia by listeners blinded to ventilation conditions	5 min
Speech quality	evaluation of speech quality by the patient using a visual analogical scale	1 minute
Speech comfort	evaluation of speech comfort by the patient using a visual analogical scale	1 minute
Respiratory comfort	evaluation of respiratory comfort by the patient using a visual analogical scale	1 minute
dyspnea	evaluation of dyspnea during speech evaluated with the modified Borg scale (ranking from 0 to10)	1 minute
oxygen saturation	evaluation of Respiratory tolerance during speech by measuring oxygen saturation	15 min
respiratory rate	evaluation of Respiratory tolerance during speech by measuring respiratory rate	15 min
cardiac frequency	evaluation of Cardiovascular tolerance during speech by measuring cardiac frequency	15 min
Patient satisfaction	evaluation of Patient satisfaction with speech with the ventilation mode by the patient using a visual analogical scale	1 minute

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Investigators: Principal Investigator: Hélène Prigent, MD PhD, Raymond Poincaré Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: non invasive ventilation; speech; invasive ventilation; neuromuscular disorder; phonation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 2017-A00109-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No