Using SleepImage to detect respiratory failure in people with ALS
Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Sclerosis
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 type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT07502677 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
London
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Professor Michael Polkey
- Email: mike.polkey@nhs.net
- Phone: 020 7352 8121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.