Home Versus Hospital Based NIV Care in MND

NCT06844370 | Recruiting

• 1 other identifier: P03084
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Neurone Disease; Respiratory Insufficiency

Keywords

non invasive ventilation

Outcome Measures

Primary Outcomes (2)

• Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2)

  Daytime PaCO2 measured by arterial puncture

  measured at 1,4,7 months following NIV initiation

• Patients and carers experiences of starting and managing NIV, and factors that relate to NIV concordance and acceptance.

  Semi-structured interview with patients and their carers

  measured at 4 weeks since starting NIV

Secondary Outcomes (12)

• NIV acceptance

  1 month

• NIV concordance

  1 , 4 and 7 months

• Survival

  Survival since NIV initiation

• Admissions

  Up to 7 months from initiation of NIV

• NIV setting changes

  1 , 4 and 7 months

Study Arms (2)

Home initiation of NIV

OTHER

Initiation of NIV at home and follow up by home visits and telemonitoring

Other: Non-invasive ventilation

Hospital initiation of NIV

OTHER

Initiation of NIV at hospital with monitoring at outpatient visits

Other: Non-invasive ventilation

Interventions

Non-invasive ventilation OTHER

Providing ventilation support through non-invasive means

Home initiation of NIV; Hospital initiation of NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• University of Nottingham: collaborator
• MND Association: collaborator

Study Sites (1)

Royal Paworth Hospital

Cambridge, CB2 0AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Dariusz Wozniak

  Royal Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dariusz Wozniak

CONTACT

01223639619; dariusz.wozniak@nhs.net

Victoria Stoneman

CONTACT

01223639865; victoria.stoneman@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Random allocation to either home or hospital based treatment

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: February 25, 2025
• Study Start: March 6, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)