{
  "FullStudy":{
    "Rank":217592,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519388",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011-A00771-40"
          },
          "Organization":{
            "OrgFullName":"Centre d'Investigation Clinique et Technologique 805",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Evaluation of the Impact on Swallowing of Non Invasive Ventilation",
          "OfficialTitle":"Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients",
          "Acronym":"OPTIDEG"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 9, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 10, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Centre d'Investigation Clinique et Technologique 805",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Adep Assistance",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"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.\n\nThe 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.\n\nSwallowing 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.\n\nOur 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.\n\nIn 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.",
          "DetailedDescription":"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.\n\nWe 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.\n\nOur 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.\n\nIn 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"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Neuromuscular Disorder",
              "Respiratory Failure",
              "Swallowing",
              "Mechanical Ventilation"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Neuromuscular disorder",
              "Respiratory failure",
              "Swallowing",
              "Mechanical ventilation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"10",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"neuromuscular patients",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Neuromuscular non invasively ventilated patients in stable at the time of the study",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Spontaneous breathing",
                    "Device: Elysée 150®"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Spontaneous breathing",
                "InterventionDescription":"study of the swallowing of boluses of water and yogurt under spontaneous breathing",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "neuromuscular patients"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"Elysée 150®",
                "InterventionDescription":"Study of the swallowing of boluses of water and yogurt while under mechanical ventilation",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "neuromuscular patients"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"impact of non invasive ventilation on swallowing efficiency",
                "PrimaryOutcomeDescription":"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",
                "PrimaryOutcomeTimeFrame":"2 Hours"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Swallow and respiration synchronisation",
                "SecondaryOutcomeDescription":"Number of swallows followed by expiration",
                "SecondaryOutcomeTimeFrame":"2 Hours"
              },{
                "SecondaryOutcomeMeasure":"Respiratory comfort",
                "SecondaryOutcomeDescription":"Evaluation of the respiratory comfort by the Borg dypnea scale",
                "SecondaryOutcomeTimeFrame":"2 Hours"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria:\n\nNeurologic or Neuromuscular restrictive respiratory failure, excluding bulbar involvement\nHospitalization in the home ventilation unit of the Raymond Poincaré Hospital\nday and night non invasive ventilation during >14hours/day\nrespiratory autonomy of at least one hour of during the day\nVentilation with an assisted and controled mode\nAdults ≥18 years\nStable patient upon inclusion\nprior Medical examination\nSigned consent form\n\nExclusion Criteria:\n\nUnstable hemodynamics\nRespiratory decompensation\nUnable to cooperate\nPerson under guardianship or trusteeship\nPregnant women\nRefusal of study participation\nNon covered by the social security system",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Helene PRIGENT, Md-PhD",
                "OverallOfficialAffiliation":"Raymond Poincare Hospital - Garches - France",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Frederic LOFASO, MD-PhD",
                "OverallOfficialAffiliation":"Raymond Poincare Hospital - Garches - France",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Raymond Poincare Hospital",
                "LocationCity":"Garches",
                "LocationZip":"92380",
                "LocationCountry":"France"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"22113817",
                "ReferenceType":"background",
                "ReferenceCitation":"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."
              },{
                "ReferencePMID":"20558065",
                "ReferenceType":"background",
                "ReferenceCitation":"Terzi 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."
              },{
                "ReferencePMID":"17110642",
                "ReferenceType":"background",
                "ReferenceCitation":"Terzi 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. Epub 2006 Nov 16."
              },{
                "ReferencePMID":"26938617",
                "ReferenceType":"derived",
                "ReferenceCitation":"Garguilo 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."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012131",
                "ConditionMeshTerm":"Respiratory Insufficiency"
              },{
                "ConditionMeshId":"D000009468",
                "ConditionMeshTerm":"Neuromuscular Diseases"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012120",
                "ConditionAncestorTerm":"Respiration Disorders"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13551",
                "ConditionBrowseLeafName":"Respiratory Insufficiency",
                "ConditionBrowseLeafAsFound":"Respiratory Failure",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10994",
                "ConditionBrowseLeafName":"Neuromuscular Diseases",
                "ConditionBrowseLeafAsFound":"Neuromuscular Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13102",
                "ConditionBrowseLeafName":"Pulmonary Valve Insufficiency",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13540",
                "ConditionBrowseLeafName":"Respiration Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              }
            ]
          }
        }
      }
    }
  }
}