Neuromuscular DisorderOPTIDEGNCT01519388
Evaluation of the Impact on Swallowing of Non Invasive Ventilation
A study testing Spontaneous breathing and Elysée 150® in people with Neuromuscular Disorder and Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of the airway muscles involved in swallowing. The investigators have shown that respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disorder, Respiratory Failure, Swallowing
- What is being tested?
- Spontaneous breathing and Elysée 150®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to May 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurologic or Neuromuscular restrictive respiratory failure, excluding bulbar involvement
- Hospitalization in the home ventilation unit of the Raymond Poincaré Hospital
- day and night non invasive ventilation during >14hours/day
- respiratory autonomy of at least one hour of during the day
- Ventilation with an assisted and controled mode
- Adults ≥18 years
Show all 9Show fewer
- Stable patient upon inclusion
- prior Medical examination
- Signed consent form
Who cannot join
- Unstable hemodynamics
- Respiratory decompensation
- Unable to cooperate
- Person under guardianship or trusteeship
- Pregnant women
- Refusal of study participation
- Non covered by the social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients
Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of the airway muscles involved in swallowing. The investigators have shown that respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular respiratory failure. Furthermore, although tracheostomy has been reported as impairing swallowing, the investigators have shown that when a tracheostomy is performed in neuromuscular patients, swallowing improves because it allows the patient to feed while ventilated.
The investigators now want to evaluate whether non invasive ventilation may have a beneficial impact on swallowing by making some adjustments to ensure a good synchronisation between ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition in neuromuscular patients.
Read more
Swallowing improvement under mechanical ventilation depends on improving the synchronisation between the patient and the ventilator during swallowing. For that purpose, the investigators developed a prototype ventilator able to temporarily suspend pressurisation under the patient's control so that when the patient needs to swallow under mechanical ventilation he may do so with an inadequate insufflation of the ventilator.
Our objective is to to demonstrate that swallowing is more adapted and easier under nasal noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring prolonged noninvasive ventilation.
In an open monocentric pilot study, the investigators will study 10 neuromuscular patients usually noninvasively ventilated. The patients will be their own control and their swallow will be studied during spontaneous breathing and under ventilation with the adapted ventilator while swallowing boluses of different volumes.
Read the detailed description
Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of airway muscles involved in swallowing. We have shown that respiratory failure may also contribute to swallowing dysfunction and that, although tracheostomy has been reported as impairing swallowing, when a tracheostomy was performed in neuromuscular patients, swallowing was improved because it allowed the patient to feed while ventilated.
We now want to evaluate whether non invasive ventilation may have a beneficial impact on swallowing considering some adjustments to ensure a good synchronisation between ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition. Improving swallowing under mechanical ventilation depends on improving the synchronisation between the patient and the ventilator during swallowing. For that purpose, we developed a prototype ventilator able to temporarily suspend pressurisation under the patient's control so that when the patient needs to swallow under mechanical ventilation he may do so with an inadequate insufflation of the ventilator.
Our objective is to to demonstrate that swallowing is more adapted and easier under nasal noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring prolonged noninvasive ventilation.
In an open monocentric pilot study, we will study 10 neuromuscular patients usually noninvasively ventilated. The patients will be their own control and their swallow will be studied during spontaneous breathing and under ventilation with the adapted ventilator while swallowing boluses of different volumes. Swallowing will be evaluated by measuring swallowing duration, numbers of swallows required for a bolus, number of respiratory cycles required for the swallow of a bolus. Order ventilation mode and bolus volume will be randomized
- Being tested
- Spontaneous breathing, Elysée 150®
- Keywords
- Neuromuscular disorder, Respiratory failure, Swallowing, Mechanical ventilation
- Medical subject headings
- Neuromuscular Diseases, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous breathingOther
study of the swallowing of boluses of water and yogurt under spontaneous breathing
Elysée 150®Device
Study of the swallowing of boluses of water and yogurt while under mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular patients | Experimental | Neuromuscular non invasively ventilated patients in stable at the time of the study Receives: Other: Spontaneous breathing; Device: Elysée 150® |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of non invasive ventilation on swallowing efficiency
Swallowing efficiency under non invasive ventilation will be evaluated by the duration of swallowing of bolus, number of swallow per bolus, number of respiratory cycles per swallowed bolus
Measured: 2 Hours
Secondary outcomes (2)
Swallow and respiration synchronisation
Number of swallows followed by expiration
Measured: 2 Hours
Respiratory comfort
Evaluation of the respiratory comfort by the Borg dypnea scale
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Adep Assistance
- Responsible party
- Sponsor
- Investigators
- Helene PRIGENT, Md-PhD, Principal investigator, Raymond Poincare Hospital - Garches - FranceFrederic LOFASO, MD-PhD, Study director, Raymond Poincare Hospital - Garches - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519388
- Sponsor's protocol ID
- 2011-A00771-40
- Acronym
- OPTIDEG
- Status last verified
- Jul 2013
- First submitted
- 23 Jan 2012
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Prigent H, Lejaille M, Terzi N, Annane D, Figere M, Orlikowski D, Lofaso F. Effect of a tracheostomy speaking valve on breathing-swallowing interaction. Intensive Care Med. 2012 Jan;38(1):85-90. doi: 10.1007/s00134-011-2417-8. Epub 2011 Nov 24.
PubMed 22113817Terzi N, Prigent H, Lejaille M, Falaize L, Annane D, Orlikowski D, Lofaso F. Impact of tracheostomy on swallowing performance in Duchenne muscular dystrophy. Neuromuscul Disord. 2010 Aug;20(8):493-8. doi: 10.1016/j.nmd.2010.05.009. Epub 2010 Jun 16.
PubMed 20558065Terzi N, Orlikowski D, Aegerter P, Lejaille M, Ruquet M, Zalcman G, Fermanian C, Raphael JC, Lofaso F. Breathing-swallowing interaction in neuromuscular patients: a physiological evaluation. Am J Respir Crit Care Med. 2007 Feb 1;175(3):269-76. doi: 10.1164/rccm.200608-1067OC. Epub 2006 Nov 16.
PubMed 17110642Garguilo M, Lejaille M, Vaugier I, Orlikowski D, Terzi N, Lofaso F, Prigent H. Noninvasive Mechanical Ventilation Improves Breathing-Swallowing Interaction of Ventilator Dependent Neuromuscular Patients: A Prospective Crossover Study. PLoS One. 2016 Mar 3;11(3):e0148673. doi: 10.1371/journal.pone.0148673. eCollection 2016.
PubMed 26938617
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients
- ClinicalTrials.gov ID
- NCT01519388
- Acronym / sponsor ID
- OPTIDEG / 2011-A00771-40
- Keywords
- Neuromuscular disorder, Respiratory failure, Swallowing, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Adep Assistance
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Jan 2012 (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.
Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of the airway muscles involved in swallowing. The investigators have shown that respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular respiratory failure. Furthermore, although tracheostomy has been reported as impairing swallowing, the investigators have shown that when a tracheostomy is performed in neuromuscular patients, swallowing improves because it allows the patient to feed while ventilated.
The investigators now want to evaluate whether non invasive ventilation may have a beneficial impact on swallowing by making some adjustments to ensure a good synchronisation between ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition in neuromuscular patients.
Swallowing improvement under mechanical ventilation depends on improving the synchronisation between the patient and the ventilator during swallowing. For that purpose, the investigators developed a prototype ventilator able to temporarily suspend pressurisation under the patient's control so that when the patient needs to swallow under mechanical ventilation he may do so with an inadequate insufflation of the ventilator.
Our objective is to to demonstrate that swallowing is more adapted and easier under nasal noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring prolonged noninvasive ventilation.
In an open monocentric pilot study, the investigators will study 10 neuromuscular patients usually noninvasively ventilated. The patients will be their own control and their swallow will be studied during spontaneous breathing and under ventilation with the adapted ventilator while swallowing boluses of different volumes.
Detailed description
Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of airway muscles involved in swallowing. We have shown that respiratory failure may also contribute to swallowing dysfunction and that, although tracheostomy has been reported as impairing swallowing, when a tracheostomy was performed in neuromuscular patients, swallowing was improved because it allowed the patient to feed while ventilated.
We now want to evaluate whether non invasive ventilation may have a beneficial impact on swallowing considering some adjustments to ensure a good synchronisation between ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition. Improving swallowing under mechanical ventilation depends on improving the synchronisation between the patient and the ventilator during swallowing. For that purpose, we developed a prototype ventilator able to temporarily suspend pressurisation under the patient's control so that when the patient needs to swallow under mechanical ventilation he may do so with an inadequate insufflation of the ventilator.
Our objective is to to demonstrate that swallowing is more adapted and easier under nasal noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring prolonged noninvasive ventilation.
In an open monocentric pilot study, we will study 10 neuromuscular patients usually noninvasively ventilated. The patients will be their own control and their swallow will be studied during spontaneous breathing and under ventilation with the adapted ventilator while swallowing boluses of different volumes. Swallowing will be evaluated by measuring swallowing duration, numbers of swallows required for a bolus, number of respiratory cycles required for the swallow of a bolus. Order ventilation mode and bolus volume will be randomized
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromuscular patients | Experimental | Other: Spontaneous breathing, Device: Elysée 150®Neuromuscular non invasively ventilated patients in stable at the time of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Neurologic or Neuromuscular restrictive respiratory failure, excluding bulbar involvement
- Hospitalization in the home ventilation unit of the Raymond Poincaré Hospital
- day and night non invasive ventilation during >14hours/day
- respiratory autonomy of at least one hour of during the day
- Ventilation with an assisted and controled mode
Key exclusion criteria (7 listed)
- Unstable hemodynamics
- Respiratory decompensation
- Unable to cooperate
- Person under guardianship or trusteeship
- Pregnant women
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 |
|---|---|---|
| Spontaneous breathingstudy of the swallowing of boluses of water and yogurt under spontaneous breathing | Other | neuromuscular patients |
| Elysée 150®Study of the swallowing of boluses of water and yogurt while under mechanical ventilation | Device | neuromuscular patients |
Primary outcome
impact of non invasive ventilation on swallowing efficiency
Time frame: 2 Hours
Swallowing efficiency under non invasive ventilation will be evaluated by the duration of swallowing of bolus, number of swallow per bolus, number of respiratory cycles per swallowed bolus
2 secondary outcomes
Swallow and respiration synchronisation
Time frame: 2 Hours
Respiratory comfort
Time frame: 2 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
- Background: PubMed 22113817Prigent H, Lejaille M, Terzi N, Annane D, Figere M, Orlikowski D, Lofaso F. Effect of a tracheostomy speaking valve on breathing-swallowing interaction. Intensive Care Med. 2012 Jan;38(1):85-90. doi: 10.1007/s00134-011-2417-8. Epub 2011 Nov 24.
- Background: PubMed 20558065Terzi N, Prigent H, Lejaille M, Falaize L, Annane D, Orlikowski D, Lofaso F. Impact of tracheostomy on swallowing performance in Duchenne muscular dystrophy. Neuromuscul Disord. 2010 Aug;20(8):493-8. doi: 10.1016/j.nmd.2010.05.009. Epub 2010 Jun 16.
- Background: PubMed 17110642Terzi N, Orlikowski D, Aegerter P, Lejaille M, Ruquet M, Zalcman G, Fermanian C, Raphael JC, Lofaso F. Breathing-swallowing interaction in neuromuscular patients: a physiological evaluation. Am J Respir Crit Care Med. 2007 Feb 1;175(3):269-76. doi: 10.1164/rccm.200608-1067OC. Epub 2006 Nov 16.
- Derived from this study: PubMed 26938617Garguilo M, Lejaille M, Vaugier I, Orlikowski D, Terzi N, Lofaso F, Prigent H. Noninvasive Mechanical Ventilation Improves Breathing-Swallowing Interaction of Ventilator Dependent Neuromuscular Patients: A Prospective Crossover Study. PLoS One. 2016 Mar 3;11(3):e0148673. doi: 10.1371/journal.pone.0148673. eCollection 2016.
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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.
Helene PRIGENT, Md-PhD principal investigator
Raymond Poincare Hospital - Garches - France
Frederic LOFASO, MD-PhD study director
Raymond Poincare Hospital - Garches - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spontaneous breathing and Elysée 150® in people with Neuromuscular Disorder and Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of non invasive ventilation on swallowing efficiency (time frame: 2 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01519388, which also lists 4 linked publications.
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 10 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.