[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"motor-neurone-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:motor-neurone-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100580981","home-versus-hospital-based-niv-care-in-mnd-100580981",false,"NCT06844370","Home Versus Hospital Based NIV Care in MND","Home Initiation and Monitoring of Non-invasive Ventilation (NIV) Versus Hospital-based Care in People with Motor Neurone Disease (MND) : a Randomised Control Trial (RCT) and Qualitative Study","HoHoNIV","Inclusion Criteria:\n\n* Adults with a diagnosis of Motor Neurone Disease confirmed by a neurologist specialising in MND.\n* Indications to NIV: daytime pCO2 \\>6.0 kPa or\u002Fand symptoms of ventilatory failure (e.g. orthopnoea, paroxysmal nocturnal dyspnoea, morning drowsiness) in the presence of significant diaphragmatic weakness confirmed by respiratory muscle tests\n\nExclusion Criteria:\n\n* Cognitive impairment precluding understanding of the study protocol and valid consent\n* Severe co-morbidities (e.g. decompensated heart failure, severe chronic obstructive pulmonary disease (COPD), morbid obesity) causing or contributing to respiratory failure\n* Immediate need to start NIV (\\\u003C24hrs) and\u002For acute illness requiring inpatient treatment e.g. intravenous antibiotics for pneumonia (in addition to the need for NIV)\n* Lack of a sufficient social\u002Fprofessional network to support NIV application at home\n* Not wishing to accept home NIV","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Non-invasive ventilation (NIV) is commonly offered to people with Motor Neurone Disease (MND) who have breathing difficulties. It improves their quality of life and can prolong life by 6 months or more. It is initially used at night and typically set up during a hospital admission. By the time that they develop respiratory failure and need to start NIV, however, most patients require wheelchairs or have other significant health problems. Repeated travel to hospitals is increasingly difficult with increasing disability. It is possible to start and monitor NIV treatment at home. This may be more convenient for selected patients, though starting NIV is quite complex; it is not known if home treatment is as safe and effective as hospital-based treatment.\n\nTo establish this, 60 patients with MND who have indications for NIV will be recruited. They will be randomly allocated to a home-based treatment (home NIV set up plus home visits supported by telemonitoring) or hospital-based care (inpatient NIV set up plus outpatient NIV monitoring) and followed up at 1, 4 and 7 months. Alongside measures of treatment effectiveness, assessment of patient and carer preferences, quality of life, and cost-effectiveness will be undertaken.\n\nIn the additional qualitative part on this study, interviews with patients who took part in the main study and their carers will be conducted to understand in more depth their perspective on what makes for a good or bad experience with NIV, how the environment (home vs hospital) influences their NIV experience and what personal factors determine NIV use. Findings from the interviews will inform the design of a truly patient-centred NIV service.",[27,28],"Motor Neurone Disease","Respiratory Insufficiency",[30],"non invasive ventilation","RECRUITING","2025-02-19",{"date":34,"type":35},"2025-02-25","ACTUAL",{"date":37,"type":35},"2024-03-06",{"date":39,"type":21},"2026-09",{"name":41,"class":42},"Papworth Hospital NHS Foundation Trust","OTHER_GOV",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100579108","measurement-and-impact-of-physical-impairment-in-amyotrophic-lateral-sclerosis-use-of-digital-technologies---a-precision-als-project-100579108","NCT06820008","Measurement and Impact of Physical Impairment in Amyotrophic Lateral Sclerosis: Use of Digital Technologies - A Precision ALS Project","TechnicALS","Inclusion Criteria:\n\n* Diagnosis of ALS made by a Neurologist; possible, lab-supported probable, probable or definite as per the revised El Escorial Criteria.\n* Enrolled in the Precision ALS prospective study.\n* Ability to understand participation requirements and provide informed consent to undergo assessments and for data to be used.\n* Willingness to use a smartphone or tablet and to download and use study apps.\n* Age \\>18 years\n* Home access to a stable broadband internet connection and willingness to use this for data collection.\n\nExclusion Criteria:\n\n* Diagnosis of a neurological disease other than ALS, active dementia or psychiatric illness that would limit ability to follow the assessment schedule of the study.\n* Other medical condition that would compromise the patient's safety or limit their participation in this study.",{"count":20,"type":21},"OBSERVATIONAL","Amyotrophic Lateral Sclerosis (ALS), the most common form of Motor Neuron Disease (MND), is a neurodegenerative disease. At present there are limited treatment options for this disease which progressively affects physical function, i.e., the ability to speak, breathe, walk, and perform activities of daily living. ALS is a rare disease, and can present differently amongst individuals, therefore global collaboration is vital to have enough participants in studies to evaluate the effects of new treatments more precisely.\n\nThere are now many novel technologies that measure physical function which could be used in research studies to allow people with ALS to participate, in-part from home, knowing that they have access to the best clinical trials but with minimal time and travel burden. Their accuracy and the ability\u002Fwillingness of people with ALS to use them need to be evaluated before they are accepted.\n\nOne of the traditional measurements used in research is called the ALS Functional Rating Scale -revised (ALSFRS-r) but this measurement has been criticised for being unable to pick up small changes and, in the digital age, outdated. The primary aim of this study is to develop a digital toolkit for more accurate measurement of physical aspects of ALS. It will test new technologies that measure physical function (i.e., walking, speech, swallow, strength, respiration (breathing), dexterity) that can be used by people with ALS in their own home.\n\nThis study has two aims:\n\nFirstly, to test a selection of new digital technologies (in the form of devices, online systems and applications used on smartphones\u002Felectronic tablets) that measure physical function (e.g., walking, speech, strength) and assess whether the technologies are easy to use and acceptable both to people with ALS\u002FMND and healthcare professionals.\n\nSecondly, to measure how good technologies are at picking up changes in physical function over time and how they compare to older measures that are usually employed by clinicians.\n\nThis study will recruit 60 people with the ALS form of MND who attend a MND clinic in Dublin, Ireland. The study will run from November 2024 to December 2027 approximately. During this period, each participant will be asked to take part for a duration of 12 months.\n\nThe study will compare measurements of physical function collected by a researcher in the traditional way, with new ways of measuring the same functions, using technologies that can be used at home by the person with ALS. The experience of people using the technologies at home will be evaluated with interviews and questionnaires.\n\nOver the 12-month duration, participants will be assessed in person by members of the research team on 3 occasions. These assessments will be carried out in the clinic setting or can be completed at the participant's home instead if needed.\n\nIn between the in-person assessments, participants will also do assessments in their own home every week using technologies, either independently or with telephone or video support from a researcher. The technologies that the participant use at home will be matched to the ones that were assigned to them for the in-person assessment at the beginning. Participants will use only technologies that are suited to them. The researcher will talk to participants about which technologies are suitable for them and which they are comfortable to use.\n\nParticipants coded data collected using the new technologies will be analyzed using established methods and newer methods such as artificial intelligence (AI). AI refers to the ability of computers and digital devices to learn and simulate human intelligence. Machine learning, a field within AI, analyses large data sets to develop models that improve as more data is added. Analysis of participants coded data will be for research purposes only and will not be used for their medical care.\n\nUltimately this study will create new knowledge on the role of technology in physical measurement in MND and how it can be successfully used in future studies to help find effective treatments.",[55,27],"Amyotrophic Lateral Sclerosis",[57,58,59,60,61,62,63,64,65,66,67],"ALS","PrecisionALS","Digital technologies","speech","swallow","dexterity","mobility","respiration","remote measurement","MND","outcome measurement","2025-02-05",{"date":70,"type":35},"2025-02-11",{"date":72,"type":35},"2024-11-21",{"date":74,"type":21},"2027-12-01",{"name":76,"class":77},"University of Dublin, Trinity College","OTHER"]