Motor Neurone DiseaseHoHoNIVNCT06844370
Home Versus Hospital Based NIV Care in MND
A study testing Non-invasive ventilation in people with Motor Neurone Disease and Respiratory Insufficiency, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Neurone Disease, Respiratory Insufficiency
- What is being tested?
- Non-invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Paworth Hospital
Cambridge, CB2 0AY
Dariusz Wozniak
About this study
Official title: 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.
- Conditions
- Motor Neurone Disease, Respiratory Insufficiency
- Being tested
- Non-invasive ventilation
- Keywords
- non invasive ventilation
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationOther
Providing ventilation support through non-invasive means
| Study group | Role | What they receive |
|---|---|---|
| Home initiation of NIV | Other | Initiation of NIV at home and follow up by home visits and telemonitoring Receives: Other: Non-invasive ventilation |
| Hospital initiation of NIV | Other | Initiation of NIV at hospital with monitoring at outpatient visits Receives: Other: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2)
Daytime PaCO2 measured by arterial puncture
Measured: 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: measured at 4 weeks since starting NIV
Secondary outcomes (12)
NIV acceptance
Percent of patients using NIV for >=4hrs/night
Measured: 1 month
NIV concordance
NIV adherence (machine usage in hours/24hours)
Measured: 1 , 4 and 7 months
Survival
Survival (in months)
Measured: Survival since NIV initiation
Admissions
Number of additional planned and emergency hospital admissions
Measured: Up to 7 months from initiation of NIV
NIV setting changes
Number of NIV setting changes required
Measured: 1 , 4 and 7 months
Cost effectiveness
Absolute costs and costs in relation to quality-adjusted life-years (using EQ-5D)
Measured: Up to 7 months from initiation of NIV
Nocturnal oximetry
time spent with oxygen saturation <90%(TST90)
Measured: 1,4,7 months
Other blood gas analysis measurements of hypoventilation
Bicarbonate
Measured: 1,4,7 months
Quality of life assessment (EQ-5D-5L)
Measurement of quality of life using EQ-5D-5L questionnaire
Measured: 1,4,7 ,months
Quality of life (SRI)
Quality of life measured using Severe Respiratory Insufficiency (SRI) questionnaire
Measured: 1,4, 7 months
Quality of sleep
Sleep quality measured with Pittsburgh Sleep Quality Index (PSQI)
Measured: 1,4,7 ,months
Satisfaction with NIV and healthcare interactions
Satisfaction with NIV and healthcare interactions measured with a visual analogue scale
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start6 Mar 2024
- Primary completionFeb 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neurone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random allocation to either home or hospital based treatment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Nottingham, MND Association
- Responsible party
- Sponsor
- Investigators
- Dariusz Wozniak, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844370
- Sponsor's protocol ID
- P03084
- Acronym
- HoHoNIV
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06844370
- Acronym / sponsor ID
- HoHoNIV / P03084
- Conditions
- Motor Neurone Disease, Respiratory Insufficiency
- Keywords
- non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- University of Nottingham, MND Association
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random allocation to either home or hospital based treatment
| Arm | Type | Receives |
|---|---|---|
| Home initiation of NIV | Other | Other: Non-invasive ventilationInitiation of NIV at home and follow up by home visits and telemonitoring |
| Hospital initiation of NIV | Other | Other: Non-invasive ventilationInitiation of NIV at hospital with monitoring at outpatient visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilationProviding ventilation support through non-invasive means | Other | Home initiation of NIV, Hospital initiation of NIV |
Primary outcome
Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2)
Time frame: measured at 1,4,7 months following NIV initiation
Daytime PaCO2 measured by arterial puncture
Patients and carers experiences of starting and managing NIV, and factors that relate to NIV concordance and acceptance.
Time frame: measured at 4 weeks since starting NIV
Semi-structured interview with patients and their carers
12 secondary outcomes
NIV acceptance
Time frame: 1 month
NIV concordance
Time frame: 1 , 4 and 7 months
Survival
Time frame: Survival since NIV initiation
Admissions
Time frame: Up to 7 months from initiation of NIV
NIV setting changes
Time frame: 1 , 4 and 7 months
Cost effectiveness
Time frame: Up to 7 months from initiation of NIV
Nocturnal oximetry
Time frame: 1,4,7 months
Other blood gas analysis measurements of hypoventilation
Time frame: 1,4,7 months
Quality of life assessment (EQ-5D-5L)
Time frame: 1,4,7 ,months
Quality of life (SRI)
Time frame: 1,4, 7 months
Quality of sleep
Time frame: 1,4,7 ,months
Satisfaction with NIV and healthcare interactions
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dariusz Wozniak principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation in people with Motor Neurone Disease and Respiratory Insufficiency, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dariusz Wozniak (01223639619, dariusz.wozniak@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2) (time frame: measured at 1,4,7 months following NIV initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.