Clinical Trials Directory

Trials / Unknown

UnknownNCT03381937

Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Centre d'Investigation Clinique et Technologique 805 · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
OTHERspeech trialspeech trial during different ventilation conditions

Timeline

Start date
2018-02-06
Primary completion
2020-01-01
Completion
2020-01-01
First posted
2017-12-22
Last updated
2019-08-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03381937. Inclusion in this directory is not an endorsement.

Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive (NCT03381937) · Clinical Trials Directory