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

NCT07502677 | Recruiting FDA Device

• 1 other identifier: SleepImage in ALS IRAS 365043
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

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

  12 hours

Secondary Outcomes (1)

• Hypoxic burden, T90, Pulse rate variability

  12 hours

Study Arms (1)

Diagnosis of ALS without NIV

Device: SleepImage

Interventions

SleepImage DEVICE

SleepImage Device

Diagnosis of ALS without NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Amyotrophic Lateral Sclerosis

You may qualify if:

• Patients aged 18 and over with a Neurologist confirmed diagnosis of ALS

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, sw3 6np, United Kingdom

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Professor Michael Polkey

CONTACT

020 7352 8121; mike.polkey@nhs.net

Lucy Redmond

CONTACT

lucy.redmond4@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 31, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 24, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-02

Locations

GB (1)