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FOUND Trial: randomised controlled trial study protocol for case finding of obstructive sleep apnoea in primary care
Michelle A Miller1, Ly-Mee Yu2, Asad Ali3
1Warwick Medical School, University of Warwick, Coventry, UK michelle.miller@warwick.ac.uk.
BMJ Open
|July 26, 2024
Summary
This study investigates the feasibility and cost-effectiveness of general practitioner-led screening for obstructive sleep apnoea (OSA). It aims to improve OSA detection rates by moving testing into primary care settings.
Area of Science:
- Clinical Medicine
- Sleep Medicine
- Primary Care Research
Background:
- Obstructive sleep apnoea (OSA) is a prevalent, underdiagnosed condition linked to severe health issues like cardiovascular disease and increased mortality.
- Current diagnostic pathways for OSA often involve specialist referrals, potentially delaying diagnosis and treatment.
- Integrating OSA testing into general practice could improve accessibility and early detection rates.
Purpose of the Study:
- To assess the feasibility of implementing obstructive sleep apnoea (OSA) testing within general practice settings.
- To determine the cost-effectiveness of a general practitioner (GP)-based screening approach for OSA.
- To evaluate the impact of GP-based screening on the overall detection rates of moderate-to-severe OSA.
Main Methods:
- A randomized controlled trial comparing a novel, MHRA-registered device (AcuPebble SA100) for OSA case finding in general practice against usual care.
- Recruitment of participants aged 50-70 with risk factors (obesity, diabetes, hypertension) from approximately 40 diverse general practices.
- The study is powered to detect a 5% difference in detection rates, with 606 patients required per arm for 90% power.
Main Results:
- Primary outcome: Comparison of moderate-to-severe OSA detection rates between the intervention (GP-based testing) and control (usual care) groups.
- Secondary outcomes: Analysis of time to diagnosis and treatment, and cost-effectiveness of different OSA testing pathways.
- The trial commenced in November 2022, with patient recruitment starting in January 2024 and planned completion in April 2025.
Conclusions:
- The findings will inform the potential shift of OSA diagnostic testing from secondary care to primary care settings.
- This research aims to provide evidence on improving the efficiency and accessibility of OSA diagnosis.
- Successful implementation could lead to earlier intervention and better management of OSA and its associated comorbidities.
