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

• ClinicalTrials.gov Identifier: NCT03381937
• Recruitment Status: Unknown
• First Posted: December 22, 2017
• Last Update Posted: August 30, 2019
• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Information provided by (Responsible Party): Centre d'Investigation Clinique et Technologique 805

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Neuromuscular Diseases; Non Invasive Ventilation	Other: speech trial	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: monocentric, open, randomize, crossover study
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation
• Actual Study Start Date: February 6, 2018
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: January 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Speech Intelligibility [ Time Frame: 1 hour ]
   assessment of intelligibility during reading of preselected words by listeners blinded to ventilation condition with a validated scale
2. Quality of prosodia [ Time Frame: 1 hour ]
   evaluation of prosodia by listeners blinded to ventilation condition with a score based on the number of correct identification
3. Phonation flow [ Time Frame: 1 hour ]
   Measurement of the number of syllables/min during the reading of a predetermined text
4. Reading duration [ Time Frame: 1 hour ]
   Measurement of the duration for the reading of a predetermined text
5. Phonation quality [ Time Frame: 1 hour ]
   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
6. Breathing quality [ Time Frame: 1 hour ]
   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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Hélène Prigent, MD PhD; 0033147107911; helene.prigent@aphp.fr

Locations

France

Raymond Poincaré hospital; Recruiting

Garches, France, 92380

Contact: Hélène Prigent, MD, PhD 0033147107911 helene.prigent@aphp.fr

Principal Investigator: Hélène Prigent, MD PhD

Sponsors and Collaborators

Centre d'Investigation Clinique et Technologique 805

More Information

• Responsible Party: Centre d'Investigation Clinique et Technologique 805
• ClinicalTrials.gov Identifier: NCT03381937
• Other Study ID Numbers: 2017-A00705-48
• First Posted: December 22, 2017
• Last Update Posted: August 30, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Investigation Clinique et Technologique 805:

mechanical ventilation; noninvasive ventilation; neuromuscular disorder; phonation; mouthpiece ventilation

Additional relevant MeSH terms:

Neuromuscular Diseases; Nervous System Diseases