Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03381937
Other study ID # 2017-A00705-48
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT04435093 - Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
Not yet recruiting NCT05785546 - Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Active, not recruiting NCT05070624 - The Peer Support Study N/A
Completed NCT04729920 - Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases
Recruiting NCT04581577 - Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
Completed NCT06428864 - Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Enrolling by invitation NCT05539456 - Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old
Completed NCT05353738 - Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
Recruiting NCT04541602 - Detection of Neuromuscular Complications in Critically Ill Patients
Completed NCT03394859 - Electronic Medical Records and Genomics (eMERGE) Phase III
Enrolling by invitation NCT05099107 - Changes of Motor Function Tests in Congenital Myopathy Subjects Treated With Oral Salbutamol as Compared to no Treatment N/A
Completed NCT05070910 - NDT Effectiveness Study N/A
Recruiting NCT04100993 - Multisystem and Autonomic Complications of NMD on Long-term NIV
Recruiting NCT04986059 - Effects of Pre-event Massage on Muscle Activity N/A
Completed NCT01022931 - Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva N/A
Terminated NCT03353064 - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure N/A