Obstructive Sleep Apnea, Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTNWL PEBBLE STT
At home testing for OSA with AcuPebble.
Sponsors
Patrik Bachtiger
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Propspective real world implementation and health economic study; historical control group for comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* OSA testing referral from primary care
Exclusion criteria
* Unable to follow test instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to diagnosis | 12 months | Time to diagnosis vs. historical control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost saving per test | 12 months | Cost saving per test in pounds sterling compared to control group |
| Test completion rate | 12 months | Completion rate as proxy for health equity |
| Financial saving to patients from cutting journeys associated with appointments | 12 months | 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. |
| Sustainability impacts by carbon footprint reduction | 12 months | 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 saving to patients from cutting journeys associated with appointments | 12 months | 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. |
Countries
United Kingdom
Contacts
Primary ContactPatrik Bachtiger
Outcome results
None listed