Neuromuscular DiseasesVentiphonoNCT03504514
Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation
A study testing speech trials during different ventilation conditions and speech trial in people with Neuromuscular Diseases and Mechanical Ventilation, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases, Mechanical Ventilation, Speech
- What is being tested?
- speech trials during different ventilation conditions and speech trial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Raymond Poincaré hospital
Garches, 92380
Hélène PRIGENT, MD PhD, 0033147107911, helene.prigent@aphp.fr
Isabelle BOSSARD, 0033147104615, isabelle.bossard@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Neuromuscular Diseases, Mechanical Ventilation, Speech
- Being tested
- speech trials during different ventilation conditions, speech trial
- Keywords
- non invasive ventilation, invasive ventilation, neuromuscular disorder, phonation, speech
- Medical subject headings
- Neuromuscular Diseases, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech trials during different ventilation conditionsDevice
ventilator parameters are modified
speech trialOther
reading duration, vocal flow, intelligibility and voice quality will be evaluated during speech
| Study group | Role | What they receive |
|---|---|---|
| Conventional mechanical ventilation | No intervention | Conventional mechanical ventilation, with patient ventilator usual parameters |
| Adapted mechanical ventilation | Experimental | Mechanical ventilation with parameters specifically modified to improve speech the effect is evaluated with speech trials during different ventilation conditions Receives: Device: speech trials during different ventilation conditions; Other: speech trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
reading duration
duration for reading a specific text in seconds
Measured: 15 minutes
Secondary outcomes (12)
Vocal flow
vocal flow in syllables/second during the reading of a specific text
Measured: 15 minutes
vocal range
vocal range from lowest to highest pitch
Measured: 2 minutes
intelligibility
evaluation of intelligibility during reading evaluated by listeners blinded to ventilation conditions
Measured: 15 minutes
Speech quality
evaluation of prosodia by listeners blinded to ventilation conditions
Measured: 5 min
Speech quality
evaluation of speech quality by the patient using a visual analogical scale
Measured: 1 minute
Speech comfort
evaluation of speech comfort by the patient using a visual analogical scale
Measured: 1 minute
Respiratory comfort
evaluation of respiratory comfort by the patient using a visual analogical scale
Measured: 1 minute
dyspnea
evaluation of dyspnea during speech evaluated with the modified Borg scale (ranking from 0 to10)
Measured: 1 minute
oxygen saturation
evaluation of Respiratory tolerance during speech by measuring oxygen saturation
Measured: 15 min
respiratory rate
evaluation of Respiratory tolerance during speech by measuring respiratory rate
Measured: 15 min
cardiac frequency
evaluation of Cardiovascular tolerance during speech by measuring cardiac frequency
Measured: 15 min
Patient satisfaction
evaluation of Patient satisfaction with speech with the ventilation mode by the patient using a visual analogical scale
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start6 Nov 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- monocentric, open, randomized, crossover study
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Prigent, MD PhD, Principal investigator, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504514
- Sponsor's protocol ID
- 2017-A00109-44
- Acronym
- Ventiphono
- Status last verified
- Aug 2019
- First submitted
- 12 Apr 2018
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03504514
- Acronym / sponsor ID
- Ventiphono / 2017-A00109-44
- Conditions
- Neuromuscular Diseases, Mechanical Ventilation, Speech
- Keywords
- non invasive ventilation, invasive ventilation, neuromuscular disorder, phonation, speech
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric, open, randomized, crossover study
| Arm | Type | Receives |
|---|---|---|
| Conventional mechanical ventilation | No intervention | –Conventional mechanical ventilation, with patient ventilator usual parameters |
| Adapted mechanical ventilation | Experimental | Device: speech trials during different ventilation conditions, Other: speech trialMechanical ventilation with parameters specifically modified to improve speech the effect is evaluated with speech trials during different ventilation conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- Refusal to participate
- Use of cuffed tracheostomy tube
- Inability to read
- Pregnancy
- Protected adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speech trials during different ventilation conditionsventilator parameters are modified | Device | Adapted mechanical ventilation |
| speech trialreading duration, vocal flow, intelligibility and voice quality will be evaluated during speech | Other | Adapted mechanical ventilation |
Primary outcome
reading duration
Time frame: 15 minutes
duration for reading a specific text in seconds
12 secondary outcomes
Vocal flow
Time frame: 15 minutes
vocal range
Time frame: 2 minutes
intelligibility
Time frame: 15 minutes
Speech quality
Time frame: 5 min
Speech quality
Time frame: 1 minute
Speech comfort
Time frame: 1 minute
Respiratory comfort
Time frame: 1 minute
dyspnea
Time frame: 1 minute
oxygen saturation
Time frame: 15 min
respiratory rate
Time frame: 15 min
cardiac frequency
Time frame: 15 min
Patient satisfaction
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Prigent, MD PhD principal investigator
Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech trials during different ventilation conditions and speech trial in people with Neuromuscular Diseases and Mechanical Ventilation, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Prigent, MD PhD (0033147107911, helene.prigent@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reading duration (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.