CClinicalTrials.gg
Status unknownNCT02097368ORDEGUpdated Jan 25, 2018

Bulbar Function in Neuromuscular Patients

An observational study in Neuromuscular Diseases, sponsored by Centre d'Investigation Clinique et Technologique 805. Status unknown at 2 sites in France. Open to participants aged 6 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
6 Years to 70 Years
Sex
All
01

Study summary

The main objective is prospectively study the upper airways function in an adult population of neuromuscular patients. The main measurement will be the evolution of tongue strength recorded each year during annual clinical evaluation on a 5 years period.

Read the detailed description

The main objective is to study the function of the superior airways (tongue and pharynx) in an non invasive way in neuromuscular patients followed in the home ventilation unit of the Raymond POINCARE hospital (myopathy, neuropathy, disease of the neuromuscular junction or anterior horn) or of Necker Hospital and to detect prematurely the bulbar dysfunction.

The secondary objectives of this prospective monocentric observational physiopathological study are:

  1. to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters
  2. to establish correlations between infraclinical or clinical and presence of morphological tongue anomalies detected by magnetic resonance imaging like in acid maltase deficiency.

The maximal tongue strength protrusion will be measured according to a method already used in the laboratory to explore sleep apnea syndromes.

Swallowing will be estimated by a non invasive method already used to highlight swallowing disorders in neurological and muscular pathologies This method will be associated with a method of recording of thoracic and abdominal movements.

Data wil be compared to a control database obtained for a previous study

02

Conditions studied

  • Neuromuscular Diseases

Keywords

  • Tongue strength
  • neuromuscular
  • swallowing
03

In context

Neuromuscular Diseases

300 studies on the registry are indexed under Neuromuscular Diseases; 87 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 121 observational studies indexed under Neuromuscular Diseases.

Browse Neuromuscular Diseases studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients affected by neuromuscular pathology

Inclusion criteria

  • neuromuscular disorder
  • age greater than or equal to 6
  • Hospitalization in Home Ventilation Unit - Written informed consent

Exclusion criteria

Exclusion Criteria:

  • patient's refusal to participate
  • major swallowing disfunction
  • Acute respiratory failure
  • no affiliation to social security
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • neuromuscular patient

    Patients affected by neuromuscular pathology will be explored by tongue strength measurement, respiratory function measurement, swallowing tests and Magnetic resonance imaging

    Procedure: tongue strength measurement · Procedure: respiratory function measurement · Procedure: swallowing tests · Other: Magnetic resonance imaging

Interventions

  • Proceduretongue strength measurement

    tongue strength measurement

  • Procedurerespiratory function measurement

    respiratory function measurement

  • Procedureswallowing tests

    swallowing tests

  • OtherMagnetic resonance imaging

    Magnetic resonance imaging

06

What researchers measure

Primary outcomes

  1. Change of tongue strength measurement

    Measurement using mechanical force transducer

    Time frame: 5 years

Secondary outcomes

  1. swallowing tests

    Non invasive measurement of swallowing function using surface electromyography, accelerometry and inductance plethysmography

    Time frame: 5 years

  2. Respiratory parameters

    Vital capacity and respiratory muscle strength measurement using spirometry and manometry

    Time frame: 5 years

  3. Vital capacity

    Spirometry

    Time frame: 5 years

  4. Respiratory muscle strength

    manometry (maximal inspiratory pressure and expiratory pressure)

    Time frame: 5 years

07

Study locations

1 of 2 sites recruiting
  • Home Ventilation Unit, Raymond Poincare Hospital
    Garches, 92380, France
    • David Orlikowski, MD, PhD · Contact · david.orlikowski@rpc.aphp.fr · 33 1 47 10 77 77
    • Marjorie Figere, CRA · Contact · marjorie.figere@rpc.aphp.fr · 33147104615
    • David Orlikowski, MD,PhD · Principal investigator
    • Helene Prigent, MD, PhD · Sub investigator
    • Frederic Lofaso, MD, PhD · Sub investigator
    Recruiting
  • Non invasive ventilation Unit - Necker Hospital
    Paris, 75015, France
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02097368
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible party
Sponsor
First posted
Mar 27, 2014
Start date
Apr 2014
Primary completion
Jan 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 25, 2018

Study contacts

David Orlikowski, MD PhD
Contact
david.orlikowski@rpc.aphp.fr
33147107777
Frederic Barbot, MD
Contact
frederic.barbot@rpc.aphp.fr
33147104474
David Orlikowski, MD, PhD
principal investigator · Centre d'Investigation Clinique et Technologique 805
Helene Prigent, MD,PhD
principal investigator · Centre d'Investigation Clinique et Technologique 805
Frederic Lofaso, MD, PhD
principal investigator · Centre d'Investigation Clinique et Technologique 805

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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