Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Sclerosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Brompton & Harefield NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SleepImage

    Device

    SleepImage Device

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Diagnosis of ALS without NIV1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 hours

Secondary outcomes

1

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

Time frame
12 hours

Other outcomes

Sponsors and contacts

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