FOUND Trial
Research type
Research Study
Full title
Case finding of obstructive sleep apnoea in primary care using a novel device: a randomised controlled trial (FOUND)
IRAS ID
323422
Contact name
Michelle A Miller
Contact email
Sponsor organisation
University of Warwick
ISRCTN Number
ISRCTN16982033
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
Obstructive Sleep Apnoea (OSA) is a sleep problem which causes the airways to become slightly or completely blocked during sleep. The brain, detecting low blood oxygen levels, sends signals to wake the person up, restoring normal breathing. OSA increases the risk of dying from heart disease and stroke. It often causes daytime sleepiness and increases risk of road traffic accidents.
Awareness of OSA in the UK is low. Up to 85% of people with OSA remain undiagnosed and untreated. Currently, a patient with OSA symptoms needs a GP referral to specialist hospital services to attend hospital, collect and be instructed on how to use the overnight sleep study equipment, return it next day and wait for data analysis and hospital follow-up appointment. Pre-pandemic, waiting time for a sleep clinic referral in Coventry was over 4 months. The AcuPebble® SA100, the first medical device to be approved for the automated diagnosis of OSA, can be posted to a patient; with results immediately calculated and sent to the hospital Sleep Specialist.
Our research aims to find out if the AcuPebble can be used in a General Practice for OSA diagnosis. We will invite patients who may be at higher risk of OSA (overweight, have hypertension, diabetes or both) to take part in the study and split into two groups. One group (intervention) will complete a home overnight sleep study using the AcuPebble. The other (control) group will continue as normal (referred to hospital via the traditional pathway if presenting a sleep study need). Individuals diagnosed with OSA in either group will be referred for treatment through existing care pathways.
We will follow up participants for six months to compare the number of new diagnoses of OSA in the two groups, looking at how well this new approach works compared to the current hospital-based referral route, and whether it is value for money for the NHS. If this strategy is successful in detecting OSA, it can be rolled out in primary care to improve the detection and treatment of OSA. Thus reducing risks, and improving health and wellbeing.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0188
Date of REC Opinion
9 Jun 2023
REC opinion
Favourable Opinion