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

Neuromuscular Diseases Clinical Trial

— PREPHONO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03381937
• Other study ID #: 2017-A00705-48
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: January 2020

Study information

• Verified date: August 2019
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: Hélène Prigent, MD PhD
• Phone: 0033147107911
• Email: helene.prigent[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Non Invasive Ventilation

Intervention

Other:
• speech trial
speech trial during different ventilation conditions

Locations

Country	Name	City	State
France	Raymond Poincaré hospital	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

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