At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mostly remote — few or no hospital visits
- Drug or intervention
- Non-invasive ventilation (other)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- Non-invasive ventilation — other: Providing ventilation support through non-invasive means
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2024-03-06
- Last checked
- 2025-02
Plain English Summary
What is this study?
- • Testing a new treatment for motor neurone disease
- • NA - 60 participants
- • Non-invasive ventilation (NIV) is commonly offered to people with Motor Neurone Disease (MND) who have breathing difficulties
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with motor neurone disease
Where?
- • Cambridge - Royal Paworth Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Adults with a diagnosis of Motor Neurone Disease confirmed by a neurologist specialising in MND.
Who cannot take part
- ✗Cognitive impairment precluding understanding of the study protocol and valid consent
- ✗Severe co-morbidities (e.g. decompensated heart failure, severe chronic obstructive lung disease (COPD), morbid...
- ✗Immediate need to start NIV (\<24hrs) and/or acute illness requiring inpatient treatment e.g. intravenous...
- ✗Lack of a sufficient social/professional network to support NIV application at home
- ✗Not wishing to accept home NIV
See the full criteria
Where Is This Study? (1 UK site)
Royal Paworth Hospital
Cambridge CB2 0AY, United Kingdom
How to Get in Touch
Dariusz Wozniak
Sponsor contactCONTACT
Victoria Stoneman
Sponsor contactCONTACT