NCT03504514

Brief Summary

Ventilation is a major treatment of respiratory failure due to neuromuscular disorders. First line treatment is noninvasive ventilation (NIV) but in some situations, especially in case of NIV inefficiency, invasive ventilation with tracheostomy (IVT) may be required. In both situations, patients may become dependent on ventilatory support with the disease evolution. Ventilation then can interfere speech and the quality of communication of the patients. Modification of the ventilation parameters may result in improved speech quality (for example, positive expiratory pressure (PEP) while not necessary for ventilation quality can dramatically improve speech in tracheostomized patients). Therefore, it would be of interest to allow patients to benefit from these specific parameters when they need to speak without maintaining them when patients are not speaking. We want to evaluate a specific ventilator feature which can detect speech and switch to specific ventilation parameters adapted for speech We believe that this feature will improve significantly speech quality in patients dependant either on NIV or IVT.

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
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 18, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

April 12, 2018

Last Update Submit

November 15, 2019

Conditions

Neuromuscular DiseasesMechanical VentilationSpeech

Keywords

non invasive ventilationinvasive ventilationneuromuscular disorderphonationspeech

Outcome Measures

Primary Outcomes (1)

  • reading duration

    duration for reading a specific text in seconds

    15 minutes

Secondary Outcomes (12)

  • Vocal flow

    15 minutes

  • vocal range

    2 minutes

  • intelligibility

    15 minutes

  • Speech quality

    5 min

  • Speech quality

    1 minute

  • +7 more secondary outcomes

Study Arms (2)

Conventional mechanical ventilation

NO INTERVENTION

Conventional mechanical ventilation, with patient ventilator usual parameters

Adapted mechanical ventilation

EXPERIMENTAL

Mechanical ventilation with parameters specifically modified to improve speech the effect is evaluated with speech trials during different ventilation conditions

Device: speech trials during different ventilation conditionsOther: speech trial

Interventions

speech trials during different ventilation conditionsDEVICE

ventilator parameters are modified

Adapted mechanical ventilation
speech trialOTHER

reading duration, vocal flow, intelligibility and voice quality will be evaluated during speech

Adapted 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)
  • Neuromuscular patients with a restrictive respiratory failure without major bulbar involvement.
  • Adult patient.
  • Ventilator dependancy= ventilation duration of 16h/day or more either with NIV or IMT
  • Leak ventilation for IMT patients
  • Respiratory autonomy of at leat 1h per day
  • Usual ventilation mode : assist control mode (either pressure or volume controlled mode) ou spontaneous breathing mode with target volume
  • Stable hemodynamic state
  • Signed informed consent

You may not qualify if:

  • Refusal to participate
  • Use of cuffed tracheostomy tube
  • Inability to read
  • Pregnancy
  • Protected adults
  • Acute respiratory failure
  • Hemodynamic 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 DiseasesSpeech

Condition Hierarchy (Ancestors)

Nervous System DiseasesVerbal BehaviorCommunicationBehavior

Study Officials

  • Hélène Prigent, MD PhD

    Raymond Poincaré Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène Prigent, MD PhD

CONTACT

0033147107911helene.prigent@aphp.fr

Isabelle BOSSARD

CONTACT

0033147104615isabelle.bossard@aphp.fr

Study Design

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

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 20, 2018

Study Start

November 6, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 18, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)