None listed
Conditions
Brief summary
Motor neurone disease (MND) is a progressive neurological disorder that results in profound disability and eventual death. Respiratory failure is the leading cause of death in MND due to declining respiratory muscle strength. Non-invasive ventilation, to support breathing, is the most effective treatment available for people living with MND. Polysomnography (PSG) is currently the gold standard for diagnosing sleep-disordered breathing and determining when to commence non-invasive ventilation in people living with motor neurone disease (MND) as it offers comprehensive monitoring of cardiac, respiratory, musculoskeletal, and neurological functioning. However, PSGs pose a significant challenge for people with MND as they require significant effort to travel to hospital and stay overnight. Also, as PSGs only collect data on the night they are conducted, they are not able to monitor the deterioration in respiratory status that is synonymous with MND. This study aims to explore the feasibility and acceptability of the use of a minimally invasive on-mattress device capable of recording body position, acoustic, respiratory and cardiac signals to identify breathing issues during sleep by people with MND and carers of people with MND. If feasible and acceptable to people with lived experience of MND, use of this device may simplify and improve the monitoring of sleep-disordered breathing in people living with motor neurone disease.
Interventions
A case control study to test the feasibility and acceptability of a new mattress sensor device (called MEDBug) when used by people living with motor neurone disease (MND). As this is a non-randomised case control study, participants will not be allocated to intervention or control randomly or by sequence. In this study, people living with MND are considered 'cases', and carers of people living with MND are considered 'controls', Both groups will be using the device and we will compare the data b
A case control study to test the feasibility and acceptability of a new mattress sensor device (called MEDBug) when used by people living with motor neurone disease (MND). As this is a non-randomised case control study, participants will not be allocated to intervention or control randomly or by sequence. In this study, people living with MND are considered 'cases', and carers of people living with MND are considered 'controls', Both groups will be using the device and we will compare the data between people living with MND (cases) and people who care for a person living with MND (controls). With instructions, participants will be asked to apply the MEDBug device to the top of their mattress, at mid-chest height with the centre line lining up with the centre of their pillow, on their usual bed in their home. The device is a sensor strip, approximately 2.5cm x 1m, that is attached to a small box which can be placed on their bedside table. The box contains a microphone that records noise spectra (not raw microphone data). The MEDBug device is installed under the bottom sheet and a mattress protector, so it will not be in direct contact or attached to the participant during use. Individuals with a diagnosis of MND and carers of individuals with a diagnosis of MND will then use the MEDBug device nightly for 1-4 weeks. On return of the device, data will be downloaded from the MEDBug device, from which a simple summary report will be created. The report will be sent to all participants (people living with MND and carers) for feedback towards future improvements. With participant and clinician consent, clinician reports will also be created for clinician review and comments towards future improvements. All participants (cases and controls) will also be asked to complete a daily diary after waking each morning to record use of non-invasive ventilation and time and reason for awakenings. The data from this diary and the data downloaded from the MEDBug device will be analysed to assess adherence to device use.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. (PwMND) Have a confirmed diagnosis of MND 2. (Carer of the pwMND) Is an unpaid/informal carer or partner of a person who has a confirmed diagnosis of MND
Exclusion criteria
1. Insufficient cognition to participate (eg. moderate to severe dementia 2. Insufficient English comprehension to read the study documents and complete sleep diaries 3. Unable or unwilling to use the MEDBug device and complete sleep diaries and questionnaires
Outcome results
None listed