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

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.

Study Overview

• Status: Unknown
• Conditions: Neuromuscular Diseases; Non Invasive Ventilation
• Intervention / Treatment: Other: speech trial

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène PRIGENT, MD PhD; Phone Number: 0033147107911; Email: helene.prigent@aphp.fr

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Raymond Poincaré Hospital
    • Contact: Hélène Prigent, MD, PhD; Phone Number: 0033147107911; Email: helene.prigent@aphp.fr
    • Principal Investigator: Hélène PRIGENT, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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®))

Exclusion Criteria:

• refusal to participate
• unability to cooperate
• illiterate patients
• tracheostomised patients
• spontaneous breathing autonomy < 1h
• cardiovascular instability
• not registered with the social security system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Spontaneous breathing; Spontaneous breathing without mechanical ventilation
Experimental: Conventional mechanical ventilation; Conventional mechanical ventilation, with patient ventilator usual parameters	Other: speech trial; speech trial during different ventilation conditions
Experimental: Speech specific mechanical ventilation; Mechanical ventilation with specific parameters to improve speech	Other: speech trial; speech trial during different ventilation conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Intelligibility	assessment of intelligibility during reading of preselected words by listeners blinded to ventilation condition with a validated scale	1 hour
Quality of prosodia	evaluation of prosodia by listeners blinded to ventilation condition with a score based on the number of correct identification	1 hour
Phonation flow	Measurement of the number of syllables/min during the reading of a predetermined text	1 hour
Reading duration	Measurement of the duration for the reading of a predetermined text	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	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	1 hour

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: mechanical ventilation; noninvasive ventilation; neuromuscular disorder; phonation; mouthpiece ventilation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 2017-A00705-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No