[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535252":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Groupe Hospitalier du Havre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MI-E with Positive expiratory pressure during pause (PEP)","EXPERIMENTAL","With the MI-E EOVE-70 device, it is possible to enable the setting of PEP (Positive Expiratory Pressure) during the pause. When this setting is activated, PEP can be adjusted between 1 and 20 cmH2O. The MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. To titrate PEP, the practitioner will start at 8 cmH2O; the setting can be decreased or increased at the discretion of the practitioner to optimize it, based on the inspiratory volume and peak expiratory flow (PEF) measured by the device at each cycle (usual clinical practice). The practitioner can adjust PEP between a minimum of 4 and a maximum of 15 cmH2O. A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm)",[13],"Device: MI-E with PEP function activated during the pause",{"label":15,"type":16,"description":17,"interventionNames":18},"MI-E without Positive expiratory pressure during pause (PEP)","ACTIVE_COMPARATOR","The MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. The PEP function will not be used by the practitioner (ie. 0 cmH2O of PEP during the pause). A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm)",[19],"Device: MI-E without PEP function activated during the pause",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MI-E with PEP function activated during the pause","PEP function will be activated during the pause when using the EOVE-70. The PEP function in cmH2O will start at 8 cmH2O; the PEP setting can be decreased or increased at the discretion of the practitioner to optimize. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"MI-E without PEP function activated during the pause","The PEP function will not be activated during the pause when using the EOVE-70. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care)",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yann Combret, PT, PhD","CONTACT","+332 32 73 32 32","yann.combret@ch-havre.fr",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"GH Havre","RECRUITING","Le Havre","Normandy","76290","France","FR",{"type":47,"coordinates":48},"Point",[49,50],0.10785,49.49346,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":26,"phoneExt":26,"email":55},"COMBRET Yann, PhD","yann.combret@gmail.com",{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[59],{"name":60,"class":61},"French Physiotherapy Society \u002F Société Français de Physiothérapie","UNKNOWN","100535252","the-importance-of-positive-expiratory-pressure-associated-with-the-in-exsufflator-in-als-patients-100535252",false,"NCT06249412","The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients","The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in Patients With Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy","PEPINEX","Inclusion Criteria:\n\n* Male or female patient aged over 18 years\n* Patient with Amyotrophic Lateral Sclerosis (ALS)\n* Patients with established or beginning bulbar disorders, identified by the healthcare team (speech impairment, hypersalivation, or swallowing difficulties)\n* Patient naive to INEX therapy but prescribed for its installation or patient already treated by an INEX device\n* Patient followed by the ALS mobile team of the Groupe Hospitalier du Havre or the CHU of Dijon\n* Patient whose disease progression kinetics is medically deemed compatible with inclusion in the study\n* Patient willing to participate in the research after receiving adequate information and the information letter.\n* Patient affiliated with social security or a beneficiary of such a scheme.\n\nExclusion Criteria:\n\n\"● Patient not presenting an episode of infection or a past episode of respiratory infection less than one month old\n\n* Mental illness interfering with the proper use of the device\n* History of laryngospasm\n* Inability to come for consultation with the ALS team of the Groupe Hospitalier du Havre or the CHU of Dijon\n* Pregnancy\n* Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship) Article L1121-8.\n* Appearance of a non-inclusion criterion\n* Refusal to participate after inclusion\n* Death from any cause\"","ALL","18 Years","100 Years",{"count":74,"type":75},11,"ESTIMATED","INTERVENTIONAL",[78],"NA","Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder that impairs motor neurons, with a life expectancy of 2 to 7 years after diagnosis. ALS manifests as 'spinal' when it primarily affects limbs, or 'bulbar' when it impairs speech and swallowing. The disease progressively weakens all skeletal muscles, causing respiratory issues and increased risk of lung infections due to ineffective coughing. Mechanical cough assistance via In-exsufflation therapy\u002F mechanical in-exsufflator devie (INEX\u002FMI-E) applies positive and negative airway pressures non-invasively to improve coughing. However, MI-E may fail in some ALS patients due to airway collapse, often related to brainstem muscle dysfunction.Research by Andersen et al. in 2017 highlighted that during MI-E, ALS patients often experience adverse laryngeal movements, which can obstruct airways and reduce the therapy's effectiveness. To combat this, they suggested individualized MI-E settings to minimize airway collapse. Modern MI-E devices, such as the EOVE-70, offer adjustable positive expiratory pressure (PEP) between cycles to potentially enhance airway stability and coughing efficiency. The current study focuses on the impact of PEP during therapy pauses on the peak expiratory flow rate in ALS patients, which could lead to improved therapeutic outcomes.",[81],"Amyotrophic Lateral Sclerosis ALS7",[83,84,85,86,87,88,89],"ALS","Amyotrophic Lateral Sclerosis","MI-E therapy","INEX therapy","Airway clearance technics","Neuromuscular disease","Cough assit","2026-01-19",{"date":92,"type":93},"2026-01-21","ACTUAL",{"date":95,"type":93},"2024-12-19",{"date":97,"type":75},"2027-03-01",{"name":5,"class":6},1]