NCT06844370 Home Versus Hospital Based NIV Care in MND
| NCT ID | NCT06844370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Papworth Hospital NHS Foundation Trust |
| Condition | Motor Neurone Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-03-06 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Dariusz Wozniak
PRINCIPAL INVESTIGATOR
Papworth Hospital NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06844370 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Motor Neurone Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06844370 currently recruiting?
Yes, NCT06844370 is actively recruiting participants. Contact the research team at dariusz.wozniak@nhs.net for enrollment information.
Where is the NCT06844370 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom.
Who is sponsoring the NCT06844370 clinical trial?
NCT06844370 is sponsored by Papworth Hospital NHS Foundation Trust. The principal investigator is Dariusz Wozniak at Papworth Hospital NHS Foundation Trust. The trial plans to enroll 60 participants.