Neuromuscular DiseasesPREPHONONCT03381937
Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation
A study testing speech trial in people with Neuromuscular Diseases and Non Invasive Ventilation, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
We want to demonstrate that modifications of the ventilation parameters are liable to improve the different characteristics of phonation (duration, intensity, prosody..) in neuromuscular patients who are dependent on non invasive ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases, Non Invasive Ventilation
- What is being tested?
- speech trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2018to Jan 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)
- chronic restrictive respiratory failure due to neuromuscular disease
- spontaneous breathing autonomy of at least one hour during the days
- stable clinical state
- patient with middle school education level (able to read)
- patients using life support ventilator ((Astral 150 (ResMed®), Elysée (ResMed®), Trilogy (Philips Respironics®), VentilogicLS (Weinman®), Vivo 40 (Breas®), PB560 ou Légendair (Covidien®), Monal T50 (Air liquide system®))
Who cannot join
- refusal to participate
- unability to cooperate
- illiterate patients
- tracheostomised patients
- spontaneous breathing autonomy < 1h
- cardiovascular 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
Hélène Prigent, MD PhD
About this study
We want to demonstrate that modifications of the ventilation parameters are liable to improve the different characteristics of phonation (duration, intensity, prosody..) in neuromuscular patients who are dependent on non invasive ventilation.
Read the detailed description
Speech and communication quality depend on respiration efficiency. The respiratory involvement observed in neuromuscular disorders can impair speech quality in patients, while the underlying disease may also contribute to alter phonation.
Nowadays, the first line treatment of neuromuscular chronic neuromuscular respiratory failure is noninvasive ventilation (NIV). With disease progression, it is used with increasingly duration during daytime. In that situation, mouthpiece ventilation is preferred as it allows efficient ventilation while being more comfortable for patients who can chose when they want to be ventilated. However, in that situation, patients do not receive ventilatory support while they are speaking which puts them in a less favorable situation for speech. We think that pre-phonation inspiratory volume is an essential part of speech quality. Without mechanical ventilation, this volume is reduced as a consequence of respiratory failure but it is liable to increase significantly if the patient used the volume delivered by the ventilator .
We believe that phonation is improved by NIV by applying specific ventilation parameters in patients dependant on mechanical ventilation. The modification could be used by neuromuscular patients to improve speech quality; the patients would then be able to use their usual ventilatory support to improve phonation and modulation of their speech.
In this crossover open labelled, randomised study, done in a single center (home ventilation unit of the referral center of Hospital Raymond Poincaré HUPIFO (University Hospital of Western Paris and Ile de France) (Garches, France)), phonation characteristics will be studied in 3 situations (during spontaneous breathing without ventilatory support, with the usual NIV parameters, with speech-specific NIV parameters) during which speech trials will be performed.
- Conditions
- Neuromuscular Diseases, Non Invasive Ventilation
- Being tested
- speech trial
- Keywords
- mechanical ventilation, noninvasive ventilation, neuromuscular disorder, phonation, mouthpiece ventilation
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech trialOther
speech trial during different ventilation conditions
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing | No intervention | Spontaneous breathing without mechanical ventilation |
| Conventional mechanical ventilation | Experimental | Conventional mechanical ventilation, with patient ventilator usual parameters Receives: Other: speech trial |
| Speech specific mechanical ventilation | Experimental | Mechanical ventilation with specific parameters to improve speech Receives: Other: speech trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phonation duration
evaluation by the measurement of the longest duration of a sustained A sound. The subject is asked to sustain a vowel as long as possible during a respiratory cycle while being recorded. Phonation duration is measured (in seconds) on the recording
Measured: 1 hour
Secondary outcomes (6)
Speech Intelligibility
assessment of intelligibility during reading of preselected words by listeners blinded to ventilation condition with a validated scale
Measured: 1 hour
Quality of prosodia
evaluation of prosodia by listeners blinded to ventilation condition with a score based on the number of correct identification
Measured: 1 hour
Phonation flow
Measurement of the number of syllables/min during the reading of a predetermined text
Measured: 1 hour
Reading duration
Measurement of the duration for the reading of a predetermined text
Measured: 1 hour
Phonation quality
evaluation of the phonation quality by the patient with a horizontal visual analogical scale ranked from 0 to 10 (0= very poor quality and 10= very good quality). The scale is 10 cm long ; the patient indicate his perceived sensation on the scale and the according measure (between 0 and 10) is recorded
Measured: 1 hour
Breathing quality
evaluation of the breating quality during speech in each condition by the patient with a horizontal visual analogical scale ranked from 0 to 10 (0= very uncomfortable and 10= very comfortable). The scale is 10 cm long ; the patient indicate his perceived sensation and the according measure (between 0 and 10) is recorded
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start6 Feb 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 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, randomize, crossover study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381937
- Sponsor's protocol ID
- 2017-A00705-48
- Acronym
- PREPHONO
- Status last verified
- Aug 2019
- First submitted
- 21 Sep 2017
- Last updated
- 30 Aug 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 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation
- ClinicalTrials.gov ID
- NCT03381937
- Acronym / sponsor ID
- PREPHONO / 2017-A00705-48
- Conditions
- Neuromuscular Diseases, Non Invasive Ventilation
- Keywords
- mechanical ventilation, noninvasive ventilation, neuromuscular disorder, phonation, mouthpiece ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 22 Dec 2017 (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.
We want to demonstrate that modifications of the ventilation parameters are liable to improve the different characteristics of phonation (duration, intensity, prosody..) in neuromuscular patients who are dependent on non invasive ventilation.
Detailed description
Speech and communication quality depend on respiration efficiency. The respiratory involvement observed in neuromuscular disorders can impair speech quality in patients, while the underlying disease may also contribute to alter phonation.
Nowadays, the first line treatment of neuromuscular chronic neuromuscular respiratory failure is noninvasive ventilation (NIV). With disease progression, it is used with increasingly duration during daytime. In that situation, mouthpiece ventilation is preferred as it allows efficient ventilation while being more comfortable for patients who can chose when they want to be ventilated. However, in that situation, patients do not receive ventilatory support while they are speaking which puts them in a less favorable situation for speech. We think that pre-phonation inspiratory volume is an essential part of speech quality. Without mechanical ventilation, this volume is reduced as a consequence of respiratory failure but it is liable to increase significantly if the patient used the volume delivered by the ventilator .
We believe that phonation is improved by NIV by applying specific ventilation parameters in patients dependant on mechanical ventilation. The modification could be used by neuromuscular patients to improve speech quality; the patients would then be able to use their usual ventilatory support to improve phonation and modulation of their speech.
In this crossover open labelled, randomised study, done in a single center (home ventilation unit of the referral center of Hospital Raymond Poincaré HUPIFO (University Hospital of Western Paris and Ile de France) (Garches, France)), phonation characteristics will be studied in 3 situations (during spontaneous breathing without ventilatory support, with the usual NIV parameters, with speech-specific NIV parameters) during which speech trials will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- monocentric, open, randomize, crossover study
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing | No intervention | –Spontaneous breathing without mechanical ventilation |
| Conventional mechanical ventilation | Experimental | Other: speech trialConventional mechanical ventilation, with patient ventilator usual parameters |
| Speech specific mechanical ventilation | Experimental | Other: speech trialMechanical ventilation with specific parameters to improve speech |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients (age > or equal to 18)
- chronic restrictive respiratory failure due to neuromuscular disease
- spontaneous breathing autonomy of at least one hour during the days
- stable clinical state
- patient with middle school education level (able to read)
Key exclusion criteria (7 listed)
- refusal to participate
- unability to cooperate
- illiterate patients
- tracheostomised patients
- spontaneous breathing autonomy < 1h
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 trialspeech trial during different ventilation conditions | Other | Conventional mechanical ventilation, Speech specific mechanical ventilation |
Primary outcome
Phonation duration
Time frame: 1 hour
evaluation by the measurement of the longest duration of a sustained A sound. The subject is asked to sustain a vowel as long as possible during a respiratory cycle while being recorded. Phonation duration is measured (in seconds) on the recording
6 secondary outcomes
Speech Intelligibility
Time frame: 1 hour
Quality of prosodia
Time frame: 1 hour
Phonation flow
Time frame: 1 hour
Reading duration
Time frame: 1 hour
Phonation quality
Time frame: 1 hour
Breathing quality
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 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.
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 trial in people with Neuromuscular Diseases and Non Invasive 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 6 inclusion and 7 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 30 Aug 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?
Phonation duration (time frame: 1 hour). 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 30 Aug 2019.