Home Versus Hospital Based NIV Care in MND

Last updated: February 19, 2025
Sponsor: Papworth Hospital NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Respiratory Failure

Lung Injury

Treatment

Non-invasive ventilation

Clinical Study ID

NCT06844370
P03084
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adults with a diagnosis of Motor Neurone Disease confirmed by a neurologistspecialising 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 presenceof significant diaphragmatic weakness confirmed by respiratory muscle tests

Exclusion

Exclusion Criteria:

  • Cognitive impairment precluding understanding of the study protocol and validconsent

  • Severe co-morbidities (e.g. decompensated heart failure, severe chronic obstructivepulmonary disease (COPD), morbid obesity) causing or contributing to respiratoryfailure

  • Immediate need to start NIV (<24hrs) and/or acute illness requiring inpatienttreatment e.g. intravenous antibiotics for pneumonia (in addition to the need forNIV)

  • Lack of a sufficient social/professional network to support NIV application at home

  • Not wishing to accept home NIV

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Non-invasive ventilation
Phase:
Study Start date:
March 06, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Royal Paworth Hospital

    Cambridge, CB2 0AY
    United Kingdom

    Active - Recruiting

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