Clinical trial Recruiting at 1 site Observational Ages 18 and up

Using SleepImage to detect respiratory failure in people with ALS

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

Run by Royal Brompton & Harefield NHS Foundation Trust · NCT07502677 · Data updated 2026-11-12

This project will try SleepImage monitoring during an overnight sleep recording to see if it can detect early respiratory failure in adults with ALS.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment15 (estimated)
SponsorRoyal Brompton & Harefield NHS Foundation Trust
Academic / other
Locations1 site (London)
StatusRecruiting
StartedMarch 24, 2026
Main results expectedSeptember 1, 2026
Study endsMarch 24, 2027
Registry record updatedMarch 31, 2026
Trial IDNCT07502677 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with a neurologist-confirmed diagnosis of ALS who are not currently using NIV, do not have known respiratory or unstable cardiac disease, and can give informed consent are the ideal candidates.

Probably not a fit

Patients already on NIV, those with known respiratory disease or unstable cardiac conditions, or those unable to give informed consent (for example due to frontotemporal dementia) are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects SleepImage recordings during participants' routine overnight sleep tests and compares those signals to the standard respiratory data collected at the visit. SleepImage uses tonometry and cardiopulmonary coupling (CPC) analysis to characterize stable versus unstable sleep and breathing patterns in addition to pulse oximetry. Researchers will compare SleepImage-derived markers of breathing instability against existing clinical and physiological measures to determine diagnostic accuracy for impending respiratory failure. The goal is to identify whether SleepImage can provide an earlier or more sensitive signal than peripheral oxygen measures alone to guide timing of noninvasive ventilation.

Why it matters

Potential benefit: If successful, SleepImage could provide earlier, noninvasive warning of respiratory failure so clinicians can start breathing support at a more appropriate time.

How similar studies have gone: SleepImage and cardiopulmonary coupling approaches are FDA-cleared for sleep analysis and have shown promise in detecting breathing instability, but applying them specifically to time NIV initiation in ALS is relatively novel with limited prior validation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Where it's running

  • Royal Brompton Hospital
    London, United Kingdom
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.