Neuromuscular DiseasesORDEGNCT02097368
Bulbar Function in Neuromuscular Patients
An observational study of Neuromuscular Diseases, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- tongue strength measurement, respiratory function measurement and swallowing tests
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2014to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients affected by neuromuscular pathology
Who may be able to join
- neuromuscular disorder
- age greater than or equal to 6
- Hospitalization in Home Ventilation Unit - Written informed consent
Who cannot join
- patient's refusal to participate
- major swallowing disfunction
- Acute respiratory failure
- no affiliation to social security
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Home Ventilation Unit, Raymond Poincare Hospital
Garches, 92380
David Orlikowski, MD, PhD, 33 1 47 10 77 77, david.orlikowski@rpc.aphp.fr
Marjorie Figere, CRA, 33147104615, marjorie.figere@rpc.aphp.fr
- Not yet recruiting
Non invasive ventilation Unit - Necker Hospital
Paris, 75015
David Orlikowski, PHD, 0033147107777, david.orlikowski@rpc.aphp.fr
Brigitte Fauroux, PHD
About this study
Official title: Prospective Evaluation of Bulbar Function in Neuromuscular Patients
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:
- to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters
- 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
- Conditions
- Neuromuscular Diseases
- Being tested
- tongue strength measurement, respiratory function measurement, swallowing tests, Magnetic resonance imaging
- Keywords
- Tongue strength, neuromuscular, swallowing
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tongue strength measurementProcedure or surgery
tongue strength measurement
respiratory function measurementProcedure or surgery
respiratory function measurement
swallowing testsProcedure or surgery
swallowing tests
Magnetic resonance imagingOther
Magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular patient | Patients affected by neuromuscular pathology will be explored by tongue strength measurement, respiratory function measurement, swallowing tests and Magnetic resonance imaging Receives: Procedure: tongue strength measurement; Procedure: respiratory function measurement; Procedure: swallowing tests; Other: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tongue strength measurement
Measurement using mechanical force transducer
Measured: 5 years
Secondary outcomes (4)
swallowing tests
Non invasive measurement of swallowing function using surface electromyography, accelerometry and inductance plethysmography
Measured: 5 years
Respiratory parameters
Vital capacity and respiratory muscle strength measurement using spirometry and manometry
Measured: 5 years
Vital capacity
Spirometry
Measured: 5 years
Respiratory muscle strength
manometry (maximal inspiratory pressure and expiratory pressure)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Orlikowski, MD, PhD, Principal investigator, Centre d'Investigation Clinique et Technologique 805Helene Prigent, MD,PhD, Principal investigator, Centre d'Investigation Clinique et Technologique 805Frederic Lofaso, MD, PhD, Principal investigator, Centre d'Investigation Clinique et Technologique 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097368
- Sponsor's protocol ID
- 2013-A00601-44
- Acronym
- ORDEG
- Status last verified
- Jan 2018
- First submitted
- 20 Dec 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Bulbar Function in Neuromuscular Patients
- ClinicalTrials.gov ID
- NCT02097368
- Acronym / sponsor ID
- ORDEG / 2013-A00601-44
- Conditions
- Neuromuscular Diseases
- Keywords
- Tongue strength, neuromuscular, swallowing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromuscular patient | – | Procedure: tongue strength measurement, Procedure: respiratory function measurement, Procedure: swallowing tests, Other: Magnetic resonance imagingPatients affected by neuromuscular pathology will be explored by tongue strength measurement, respiratory function measurement, swallowing tests and Magnetic resonance imaging |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients affected by neuromuscular pathology
Key inclusion criteria (3 listed)
- neuromuscular disorder
- age greater than or equal to 6
- Hospitalization in Home Ventilation Unit - Written informed consent
Key exclusion criteria (4 listed)
- patient's refusal to participate
- major swallowing disfunction
- Acute respiratory failure
- no affiliation to social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tongue strength measurementtongue strength measurement | Procedure or surgery | neuromuscular patient |
| respiratory function measurementrespiratory function measurement | Procedure or surgery | neuromuscular patient |
| swallowing testsswallowing tests | Procedure or surgery | neuromuscular patient |
| Magnetic resonance imagingMagnetic resonance imaging | Other | neuromuscular patient |
Primary outcome
Change of tongue strength measurement
Time frame: 5 years
Measurement using mechanical force transducer
4 secondary outcomes
swallowing tests
Time frame: 5 years
Respiratory parameters
Time frame: 5 years
Vital capacity
Time frame: 5 years
Respiratory muscle strength
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Orlikowski, MD PhD (33147107777, david.orlikowski@rpc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of tongue strength measurement (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.