An interventional study of speech trial in Neuromuscular Diseases and Non Invasive Ventilation, sponsored by Centre d'Investigation Clinique et Technologique 805. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Centre d'Investigation Clinique et Technologique 805 · Not applicable, Interventional, and Supportive care
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Among 23 studies in Neuromuscular Diseases by Centre d'Investigation Clinique et Technologique 805 — none open to participants now, none under way, none of them phase 3. Neuromuscular Diseases · Centre d'Investigation Clinique et Technologique 805.
Among the 23 studies in Neuromuscular Diseases by Centre d'Investigation Clinique et Technologique 805, this one is the 10th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 12 with no phase, and was the 20th registered.
361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.
Browse Neuromuscular Diseases studies →None of the 23 studies in Neuromuscular Diseases by Centre d'Investigation Clinique et Technologique 805 is open now. The open studies under Neuromuscular Diseases, anywhere →
Of the 70 Neuromuscular Diseases studies recruiting now, 39 (56%) set no upper age limit and 23 (33%) stop at 75 or younger; 36 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 15 is below the median of 30 across 204 interventional studies indexed under Neuromuscular Diseases.
Median enrollment 20 across the 13 interventional studies, 89 across the 10 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.
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Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Neuromuscular Diseases by Centre d'Investigation Clinique et Technologique 805, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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Exclusion Criteria:
Spontaneous breathing without mechanical ventilation
Conventional mechanical ventilation, with patient ventilator usual parameters
Other: speech trial
Mechanical ventilation with specific parameters to improve speech
Other: speech trial
speech trial during different ventilation conditions
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
Time frame: 1 hour
Speech Intelligibility
assessment of intelligibility during reading of preselected words by listeners blinded to ventilation condition with a validated scale
Time frame: 1 hour
Quality of prosodia
evaluation of prosodia by listeners blinded to ventilation condition with a score based on the number of correct identification
Time frame: 1 hour
Phonation flow
Measurement of the number of syllables/min during the reading of a predetermined text
Time frame: 1 hour
Reading duration
Measurement of the duration for the reading of a predetermined text
Time frame: 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
Time frame: 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
Time frame: 1 hour
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Jan 2020, 23 months after the start.
Of 75 non-industry interventional studies with no phase under Neuromuscular Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's planned 23 months is below that.
Counting every sponsor, half of 84 studies reached it within 25 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Centre d'Investigation Clinique et Technologique 805