Home Versus Hospital Based NIV Care in MND (HoHoNIV)

Home Initiation and Monitoring of Non-invasive Ventilation (NIV) Versus Hospital-based Care in People with Motor Neurone Disease (MND) : a Randomised Control Trial (RCT) and Qualitative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency; Motor Neurone Disease
• Intervention / Treatment: Other: Non-invasive ventilation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dariusz Wozniak; Phone Number: 01223639619; Email: dariusz.wozniak@nhs.net
• Study Contact Backup: Name: Victoria Stoneman; Phone Number: 01223639865; Email: victoria.stoneman@nhs.net

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Recruiting
    • Royal Paworth Hospital
    • Contact: Dariusz Wozniak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Home initiation of NIV; Initiation of NIV at home and follow up by home visits and telemonitoring	Other: Non-invasive ventilation; Providing ventilation support through non-invasive means
Other: Hospital initiation of NIV; Initiation of NIV at hospital with monitoring at outpatient visits	Other: Non-invasive ventilation; Providing ventilation support through non-invasive means

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIV acceptance	Percent of patients using NIV for >=4hrs/night	1 month
NIV concordance	NIV adherence (machine usage in hours/24hours)	1 , 4 and 7 months
Survival	Survival (in months)	Survival since NIV initiation
Admissions	Number of additional planned and emergency hospital admissions	Up to 7 months from initiation of NIV
NIV setting changes	Number of NIV setting changes required	1 , 4 and 7 months
Cost effectiveness	Absolute costs and costs in relation to quality-adjusted life-years (using EQ-5D)	Up to 7 months from initiation of NIV
Nocturnal oximetry	time spent with oxygen saturation <90%(TST90)	1,4,7 months
Other blood gas analysis measurements of hypoventilation	Bicarbonate	1,4,7 months
Quality of life assessment (EQ-5D-5L)	Measurement of quality of life using EQ-5D-5L questionnaire	1,4,7 ,months
Quality of life (SRI)	Quality of life measured using Severe Respiratory Insufficiency (SRI) questionnaire	1,4, 7 months
Quality of sleep	Sleep quality measured with Pittsburgh Sleep Quality Index (PSQI)	1,4,7 ,months
Satisfaction with NIV and healthcare interactions	Satisfaction with NIV and healthcare interactions measured with a visual analogue scale	7 months

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Collaborators: University of Nottingham; MND Association
• Investigators: Principal Investigator: Dariusz Wozniak, Royal Papworth Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: non invasive ventilation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Respiratory Insufficiency; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: P03084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No