Comparing home and hospital care for non-invasive ventilation in motor neurone disease
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
This study is testing whether using non-invasive ventilation at home can help people with Motor Neurone Disease breathe better and live more comfortably compared to getting treatment in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Papworth Hospital NHS Foundation Trust Government |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT06844370 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of home-based non-invasive ventilation (NIV) compared to traditional hospital-based care for patients with Motor Neurone Disease (MND) experiencing respiratory insufficiency. It aims to recruit 60 patients who will be randomly assigned to receive either home NIV setup with telemonitoring or hospital-based treatment. The goal is to determine if home treatment can provide similar benefits in terms of quality of life and survival while being more convenient for patients with increasing disabilities. The study addresses the challenges faced by patients who find frequent hospital visits difficult due to their condition.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Motor Neurone Disease who require non-invasive ventilation due to respiratory failure symptoms.
Not a fit: Patients with severe co-morbidities or those who cannot manage home NIV due to cognitive impairment or lack of support will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more convenient and equally effective option for managing respiratory difficulties in patients with MND.
How similar studies have performed: While the approach of home NIV is promising, it is not widely tested in this specific patient population, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cambridge
- Royal Paworth Hospital — Cambridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Dariusz Wozniak — Royal Papworth Hospital NHS Foundation Trust
- Study coordinator: Dariusz Wozniak
- Email: dariusz.wozniak@nhs.net
- Phone: 01223639619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.