About this trial
The specific aim of this study is to try to discover the diagnostic accuracy of SleepImage technology for detecting respiratory failure in patients with MND. Importantly, this research project is not about NIV, it is about what method can most efficiently decide when to start NIV.
To do this we'd like to collect data about you and your breathing from the SleepImage device when you come in for your routine overnight sleep study. We will compare this against the data that we would collect anyway.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 and over with a Neurologist confirmed diagnosis of ALS
Disqualifiers
Patients with known respiratory disease
Unstable cardiac disease, stable hypertension or ischaemic heart disease
Current NIV use
Inability to give consent (expected ~15% due to frontotemporal dementia)
Trial population
Amyotrophic Lateral Sclerosis
Trial design
Cohort
Prospective
Treatments tested in this trial
SleepImage
DeviceSleepImage Device
Treatment groups
Trial outcomes
Primary outcomes
SQI & e-LFCNB>2
We hypothesise that a SQI \<55 and Periodicity e-LFCNB\>2 has a positive association with an accepted indication for NIV initiation in ALS defined as: * Daytime Carbon Dioxide \>6.0kPa and a rise of \>1kPa from baseline in a time course consistent with REM sleep * Bicarbonate levels \>32mmol/L * SNIP \<40cmH20 in patients with non-bulbar disease * Supine fall in VC of 20% from erect in patient able to undertake the manoeuvre
Secondary outcomes
Hypoxic burden, T90, Pulse rate variability
The secondary endpoints of the study are to evaluate additional outputs generated by the SleepImage device and determine their association with the same established clinical criteria for NIV initiation in ALS. Specifically, the secondary analyses will focus on: * Hypoxic burden * SpO₂ time below 90% (T90). * Pulse rate variability
Sponsors and contacts
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