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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 : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuromuscular Diseases Mechanical Ventilation Speech Device: speech trials during different ventilation conditions Other: speech trial Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. reading duration [ Time Frame: 15 minutes ]
    duration for reading a specific text in seconds


Secondary Outcome Measures :
  1. Vocal flow [ Time Frame: 15 minutes ]
    vocal flow in syllables/second during the reading of a specific text

  2. vocal range [ Time Frame: 2 minutes ]
    vocal range from lowest to highest pitch

  3. intelligibility [ Time Frame: 15 minutes ]
    evaluation of intelligibility during reading evaluated by listeners blinded to ventilation conditions

  4. Speech quality [ Time Frame: 5 min ]
    evaluation of prosodia by listeners blinded to ventilation conditions

  5. Speech quality [ Time Frame: 1 minute ]
    evaluation of speech quality by the patient using a visual analogical scale

  6. Speech comfort [ Time Frame: 1 minute ]
    evaluation of speech comfort by the patient using a visual analogical scale

  7. Respiratory comfort [ Time Frame: 1 minute ]
    evaluation of respiratory comfort by the patient using a visual analogical scale

  8. dyspnea [ Time Frame: 1 minute ]
    evaluation of dyspnea during speech evaluated with the modified Borg scale (ranking from 0 to10)

  9. oxygen saturation [ Time Frame: 15 min ]
    evaluation of Respiratory tolerance during speech by measuring oxygen saturation

  10. respiratory rate [ Time Frame: 15 min ]
    evaluation of Respiratory tolerance during speech by measuring respiratory rate

  11. cardiac frequency [ Time Frame: 15 min ]
    evaluation of Cardiovascular tolerance during speech by measuring cardiac frequency

  12. Patient satisfaction [ Time Frame: 1 minute ]
    evaluation of Patient satisfaction with speech with the ventilation mode by the patient using a visual analogical scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Hélène Prigent, MD PhD 0033147107911 helene.prigent@aphp.fr
Contact: Isabelle BOSSARD 0033147104615 isabelle.bossard@aphp.fr

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

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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03504514     History of Changes
Other Study ID Numbers: 2017-A00109-44
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
non invasive ventilation
invasive ventilation
neuromuscular disorder
phonation
speech

Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases