An interventional study of NWL PEBBLE STT in Obstructive Sleep Apnea and Sleep Apnea, sponsored by Patrik Bachtiger. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Patrik Bachtiger · Not applicable, Interventional, and Diagnostic
Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Current diagnostic approaches are expensive (£391), time-consuming (>1-hour interpretation), uncomfortable (cables/tubes/wires), and inequitable (multiple hospital visits). Overcoming all these limitations, we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA. This will use the AcuPebble, a miniature wearable acoustic sensor and the first regulated technology for automated, at-home diagnosis. The test is cheap (\< £100); time-saving; endorsed by patients, and accessible (posted directly to patients). This project will measure the impact of a potentially transformative, innovative, and scalable diagnostic pathway using AcuPebble technology.
The investigators are conducting a prospective implementation and health economic study of a novel straight-to-test (STT) clinical diagnostic pathway for OSA, using a novel, regulatory-approved wearable medical device for automated diagnosis of OSA in the home setting (AcuPebble SA100). The setting is real-world direct clinical care, with participation from three NHS sleep medicine centres servicing the North West London region.
Inclusion criteria is primary care referrals for OSA investigation were triaged onto the pathway based on predetermined criteria, compared to a historical cohort of patients undergoing STT using cardiorespiratory polygraphy (CR-PG) technology serving as a control group. The primary outcome is time-to-diagnosis. Secondary outcomes include NHS cost-saving per patient; surrogates for health equity (e.g. test completion rates, time/cost of journeys saved); and carbon footprint reduction from averted patient journeys (sustainability).
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's planned enrollment of 200 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →This is the only study on the registry with Patrik Bachtiger as lead sponsor.
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Exclusion Criteria:
Real-world clinical care arm investigating novel pathway
Diagnostic Test: NWL PEBBLE STT
At home testing for OSA with AcuPebble.
Time to diagnosis
Time to diagnosis vs. historical control group
Time frame: 12 months
Cost saving per test
Cost saving per test in pounds sterling compared to control group
Time frame: 12 months
Test completion rate
Completion rate as proxy for health equity
Time frame: 12 months
Financial saving to patients from cutting journeys associated with appointments
Cost saved from averted journeys by per patient cost of public transport and time taken to travel; informed by mapping journey per patient post-code to sleep study centre.
Time frame: 12 months
Sustainability impacts by carbon footprint reduction
CO2 footprint from averted technologies (reduced plastic waste) and reduced patient journeys (CO2 footprint reduction from miles travelled, calculated using Echochain carbon footprint calculator).
Time frame: 12 months
Time saving to patients from cutting journeys associated with appointments
Time saved from averted journeys by per patient cost of public transport and time taken to travel; informed by mapping journey per patient post-code to sleep study centre.
Time frame: 12 months
Plan to share: No — Sharable upon reasonable request.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2024, 5 months after the start.
Of 511 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 5 months is below that.
Counting every sponsor, half of 621 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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