NCT03381937

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

September 21, 2017

Last Update Submit

August 29, 2019

Conditions

Neuromuscular DiseasesNon Invasive Ventilation

Keywords

mechanical ventilationnoninvasive ventilationneuromuscular disorderphonationmouthpiece ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Speech Intelligibility

    1 hour

  • Quality of prosodia

    1 hour

  • Phonation flow

    1 hour

  • Reading duration

    1 hour

  • Phonation quality

    1 hour

  • +1 more secondary outcomes

Study Arms (3)

Spontaneous breathing

NO INTERVENTION

Spontaneous breathing without mechanical ventilation

Conventional mechanical ventilation

EXPERIMENTAL

Conventional mechanical ventilation, with patient ventilator usual parameters

Other: speech trial

Speech specific mechanical ventilation

EXPERIMENTAL

Mechanical ventilation with specific parameters to improve speech

Other: speech trial

Interventions

speech trialOTHER

speech trial during different ventilation conditions

Conventional mechanical ventilationSpeech specific mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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®))

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raymond Poincaré hospital

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Hélène Prigent, MD PhD

CONTACT

0033147107911helene.prigent@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: monocentric, open, randomize, crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2017

First Posted

December 22, 2017

Study Start

February 6, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)