Comparing home and hospital care for non-invasive ventilation in motor neurone disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Royal Paworth Hospital
  Cambridge, United Kingdom Recruiting

Study contacts

• Principal investigator: Dariusz Wozniak — Papworth Hospital NHS Foundation Trust
• Study coordinator: Dariusz Wozniak
• Email: dariusz.wozniak@nhs.net
• Phone: 01223639619

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.