NCT06844370Recruiting
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
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 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. In 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Mar 2024
- Start date
- 6 Mar 2024
- Primary completion date
- Feb 2026
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06844370
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 6 Mar 2024 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Lack of a sufficient social/professional network to support NIV application at home
- Not wishing to accept home NIV
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Paworth Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.