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Home Versus Hospital Based NIV Care in MND

RecruitingNAAges 18 Years - anyAllPapworth Hospital NHS Foundation Trust
NCT06844370 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. To establish this, 60 patients with MND who have indications for NIV will be recruited. They will be randomly allocated to a home-based tr

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults with a diagnosis of Motor Neurone Disease confirmed by a neurologist specialising in MND. * Indications to NIV: daytime pCO2 \>6.0 kPa or/and symptoms of ventilatory failure (e.g. orthopnoea, paroxysmal nocturnal dyspnoea, morning drowsiness) in the presence of significant diaphragmatic weakness confirmed by respiratory muscle tests Exclusion Criteria: * Cognitive impairment precluding understanding of the study protocol and valid consent * Severe co-morbidities (e.g. decompensated heart failure, severe chronic obstructive pulmonary disease (COPD), morbid obesity) causing or contributing to respiratory failure * Immediate need to start NIV (\<24hrs) and/or acute illness requiring inpatient treatment e.g. intravenous antibiotics for pneumonia (in addition to the need for NIV) * Lack of a sufficient social/professional network to support NIV application at home * Not wishing to accept home NIV
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What it tests

  • Non-invasive ventilation
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Where

1 site
Royal Paworth Hospital
Cambridge, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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