At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- NWL PEBBLE STT (diagnostic test)
- How long the study runs
- Study runs about 17 months (dates as stated)
- About the drug or intervention
- NWL PEBBLE STT — diagnostic test: At home testing for OSA with AcuPebble.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2024-07-07
- Last checked
- 2024-07
Plain English Summary
What is this study?
- • Testing a new treatment for obstructive sleep apnea
- • NA - 200 participants
- • Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with obstructive sleep apnea
Where?
- • London - Charing Cross Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓OSA testing referral from primary care
Who cannot take part
- ✗Unable to follow test instructions
See the full criteria
Where Is This Study? (1 UK site)
Charing Cross Hospital
London W12 0HS, United Kingdom
How to Get in Touch
Patrik Bachtiger
Sponsor contactCONTACT