Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation (PREPHONO)
Primary Purpose
Neuromuscular Diseases, Non Invasive Ventilation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
speech trial
Sponsored by
About this trial
This is an interventional supportive care trial for Neuromuscular Diseases focused on measuring mechanical ventilation, noninvasive ventilation, neuromuscular disorder, phonation, mouthpiece ventilation
Eligibility 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
Sites / Locations
- Raymond Poincaré hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Spontaneous breathing
Conventional mechanical ventilation
Speech specific mechanical ventilation
Arm Description
Spontaneous breathing without mechanical ventilation
Conventional mechanical ventilation, with patient ventilator usual parameters
Mechanical ventilation with specific parameters to improve speech
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Speech Intelligibility
assessment of intelligibility during reading of preselected words by listeners blinded to ventilation condition with a validated scale
Quality of prosodia
evaluation of prosodia by listeners blinded to ventilation condition with a score based on the number of correct identification
Phonation flow
Measurement of the number of syllables/min during the reading of a predetermined text
Reading duration
Measurement of the duration for the reading of a predetermined text
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
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
Full Information
NCT ID
NCT03381937
First Posted
September 21, 2017
Last Updated
August 29, 2019
Sponsor
Centre d'Investigation Clinique et Technologique 805
1. Study Identification
Unique Protocol Identification Number
NCT03381937
Brief Title
Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation
Acronym
PREPHONO
Official Title
Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases, Non Invasive Ventilation
Keywords
mechanical ventilation, noninvasive ventilation, neuromuscular disorder, phonation, mouthpiece ventilation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
monocentric, open, randomize, crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spontaneous breathing
Arm Type
No Intervention
Arm Description
Spontaneous breathing without mechanical ventilation
Arm Title
Conventional mechanical ventilation
Arm Type
Experimental
Arm Description
Conventional mechanical ventilation, with patient ventilator usual parameters
Arm Title
Speech specific mechanical ventilation
Arm Type
Experimental
Arm Description
Mechanical ventilation with specific parameters to improve speech
Intervention Type
Other
Intervention Name(s)
speech trial
Intervention Description
speech trial during different ventilation conditions
Primary Outcome Measure Information:
Title
Phonation duration
Description
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
Secondary Outcome Measure Information:
Title
Speech Intelligibility
Description
assessment of intelligibility during reading of preselected words by listeners blinded to ventilation condition with a validated scale
Time Frame
1 hour
Title
Quality of prosodia
Description
evaluation of prosodia by listeners blinded to ventilation condition with a score based on the number of correct identification
Time Frame
1 hour
Title
Phonation flow
Description
Measurement of the number of syllables/min during the reading of a predetermined text
Time Frame
1 hour
Title
Reading duration
Description
Measurement of the duration for the reading of a predetermined text
Time Frame
1 hour
Title
Phonation quality
Description
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
Title
Breathing quality
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Prigent, MD PhD
Phone
0033147107911
Email
helene.prigent@aphp.fr
Facility Information:
Facility Name
Raymond Poincaré hospital
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Prigent, MD, PhD
Phone
0033147107911
Email
helene.prigent@aphp.fr
First Name & Middle Initial & Last Name & Degree
Hélène Prigent, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation
We'll reach out to this number within 24 hrs