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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)

Primary Purpose

Neuromuscular Diseases, Mechanical Ventilation, Speech

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
speech trials during different ventilation conditions
speech trial
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuromuscular Diseases focused on measuring non invasive ventilation, invasive ventilation, neuromuscular disorder, phonation, speech

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Raymond Poincaré hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional mechanical ventilation

Adapted mechanical ventilation

Arm Description

Conventional mechanical ventilation, with patient ventilator usual parameters

Mechanical ventilation with parameters specifically modified to improve speech the effect is evaluated with speech trials during different ventilation conditions

Outcomes

Primary Outcome Measures

reading duration
duration for reading a specific text in seconds

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2018
Last Updated
November 15, 2019
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT03504514
Brief Title
Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation
Acronym
Ventiphono
Official Title
Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases, Mechanical Ventilation, Speech
Keywords
non invasive ventilation, invasive ventilation, neuromuscular disorder, phonation, speech

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
monocentric, open, randomized, crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional mechanical ventilation
Arm Type
No Intervention
Arm Description
Conventional mechanical ventilation, with patient ventilator usual parameters
Arm Title
Adapted mechanical ventilation
Arm Type
Experimental
Arm Description
Mechanical ventilation with parameters specifically modified to improve speech the effect is evaluated with speech trials during different ventilation conditions
Intervention Type
Device
Intervention Name(s)
speech trials during different ventilation conditions
Intervention Description
ventilator parameters are modified
Intervention Type
Other
Intervention Name(s)
speech trial
Intervention Description
reading duration, vocal flow, intelligibility and voice quality will be evaluated during speech
Primary Outcome Measure Information:
Title
reading duration
Description
duration for reading a specific text in seconds
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Vocal flow
Description
vocal flow in syllables/second during the reading of a specific text
Time Frame
15 minutes
Title
vocal range
Description
vocal range from lowest to highest pitch
Time Frame
2 minutes
Title
intelligibility
Description
evaluation of intelligibility during reading evaluated by listeners blinded to ventilation conditions
Time Frame
15 minutes
Title
Speech quality
Description
evaluation of prosodia by listeners blinded to ventilation conditions
Time Frame
5 min
Title
Speech quality
Description
evaluation of speech quality by the patient using a visual analogical scale
Time Frame
1 minute
Title
Speech comfort
Description
evaluation of speech comfort by the patient using a visual analogical scale
Time Frame
1 minute
Title
Respiratory comfort
Description
evaluation of respiratory comfort by the patient using a visual analogical scale
Time Frame
1 minute
Title
dyspnea
Description
evaluation of dyspnea during speech evaluated with the modified Borg scale (ranking from 0 to10)
Time Frame
1 minute
Title
oxygen saturation
Description
evaluation of Respiratory tolerance during speech by measuring oxygen saturation
Time Frame
15 min
Title
respiratory rate
Description
evaluation of Respiratory tolerance during speech by measuring respiratory rate
Time Frame
15 min
Title
cardiac frequency
Description
evaluation of Cardiovascular tolerance during speech by measuring cardiac frequency
Time Frame
15 min
Title
Patient satisfaction
Description
evaluation of Patient satisfaction with speech with the ventilation mode by the patient using a visual analogical scale
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Prigent, MD PhD
Phone
0033147107911
Email
helene.prigent@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle BOSSARD
Phone
0033147104615
Email
isabelle.bossard@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Prigent, MD PhD
Organizational Affiliation
Raymond Poincaré Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raymond Poincaré hospital
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène PRIGENT, MD PhD
Phone
0033147107911
Email
helene.prigent@aphp.fr
First Name & Middle Initial & Last Name & Degree
Isabelle BOSSARD
Phone
0033147104615
Email
isabelle.bossard@aphp.fr
First Name & Middle Initial & Last Name & Degree
Hélène PRIGENT, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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