NCT02097368

Brief 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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

December 20, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

December 20, 2013

Last Update Submit

January 24, 2018

Conditions

Neuromuscular Diseases

Keywords

Tongue strengthneuromuscularswallowing

Outcome Measures

Primary Outcomes (1)

  • Change of tongue strength measurement

    Measurement using mechanical force transducer

    5 years

Secondary Outcomes (4)

  • swallowing tests

    5 years

  • Respiratory parameters

    5 years

  • Vital capacity

    5 years

  • Respiratory muscle strength

    5 years

Study Arms (1)

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 measurementProcedure: respiratory function measurementProcedure: swallowing testsOther: Magnetic resonance imaging

Interventions

tongue strength measurementPROCEDURE

tongue strength measurement

neuromuscular patient
respiratory function measurementPROCEDURE

respiratory function measurement

neuromuscular patient
swallowing testsPROCEDURE

swallowing tests

neuromuscular patient
Magnetic resonance imagingOTHER

Magnetic resonance imaging

neuromuscular patient

Eligibility Criteria

Age6 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients affected by neuromuscular pathology

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Home Ventilation Unit, Raymond Poincare Hospital

Garches, 92380, France

RECRUITING

Non invasive ventilation Unit - Necker Hospital

Paris, 75015, France

NOT YET RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • David Orlikowski, MD, PhD

    Centre d'Investigation Clinique et Technologique 805

    PRINCIPAL INVESTIGATOR

  • Helene Prigent, MD,PhD

    Centre d'Investigation Clinique et Technologique 805

    PRINCIPAL INVESTIGATOR

  • Frederic Lofaso, MD, PhD

    Centre d'Investigation Clinique et Technologique 805

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Orlikowski, MD PhD

CONTACT

33147107777david.orlikowski@rpc.aphp.fr

Frederic Barbot, MD

CONTACT

33147104474frederic.barbot@rpc.aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

March 27, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2019

Study Completion

December 1, 2020

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

FR(2)