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Search / Trial NCT06844370

Home Versus Hospital Based NIV Care in MND

Launched by PAPWORTH HOSPITAL NHS FOUNDATION TRUST · Feb 19, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Non Invasive Ventilation

ClinConnect Summary

This clinical trial is studying two different ways to provide non-invasive ventilation (NIV) care for people with Motor Neurone Disease (MND) who have trouble breathing. NIV is a treatment that helps patients breathe better, and it can improve their quality of life and even extend their lives by several months. Traditionally, this treatment starts in the hospital, which can be challenging for patients as their condition progresses and they may have trouble traveling. This trial will compare receiving NIV care at home versus in the hospital to see which option is safer and more effective for patients.

To participate in this trial, you need to be an adult diagnosed with MND by a specialist and have specific breathing issues that require NIV. The study is currently looking for participants aged 65 to 74, and individuals will be randomly assigned to either home-based or hospital-based care. Throughout the trial, participants will be monitored at different intervals, and their experiences, quality of life, and preferences will be explored. This trial aims to understand what makes NIV care more comfortable and effective, ultimately helping to create a better service for patients and their families.

Gender

ALL

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

About Papworth Hospital Nhs Foundation Trust

Papworth Hospital NHS Foundation Trust is a leading healthcare institution in the United Kingdom, renowned for its specialized services in cardiothoracic medicine and surgery. As a prominent clinical trial sponsor, the Trust is dedicated to advancing medical research and improving patient outcomes through innovative trials and studies. With a commitment to excellence in patient care, Papworth Hospital collaborates with various stakeholders, including academic institutions and pharmaceutical companies, to facilitate cutting-edge research that addresses critical health challenges. The Trust's experienced team of clinicians and researchers is focused on delivering high-quality evidence that contributes to the advancement of healthcare practices and therapies.

Locations

Cambridge, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Dariusz Wozniak

Principal Investigator

Royal Papworth Hospital NHS Foundation Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported