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Contact Information:

Dr Emma Scott
+44 24 7657 4654
e.j.scott@warwick.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A randomised controlled trial to identify Obstructive Sleep Apnoea (OSA) in primary care
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A randomised controlled trial to identify Obstructive Sleep Apnoea (OSA) in primary care

Not Recruiting

Open to: All Genders

Age: Adult

Coventry

Medical Conditions

Case finding of obstructive sleep apnoea in primary care

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Obstructive Sleep Apnoea (OSA) is a sleep problem which causes the breathing tubes to become slightly or completely blocked during sleep. The brain, detecting low blood oxygen levels, sends signals that causes the person to wake 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 levels of OSA in the UK are low. It is estimated that up to 85% of people with OSA remain undiagnosed and untreated. Currently a patient with symptoms that indicate OSA 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 referral to a sleep clinic in Coventry was over 4 months. The AcuPebble SA100, the first medical device to obtain official product approval for the automated diagnosis of OSA, can be posted to a patient; with results immediately calculated and sent to the hospital Sleep Specialist. The British Lung Foundation estimated the annual savings to the NHS in the UK would be £28 million, if all people with moderate to severe OSA were diagnosed and treated.
Our research aims to find out if the AcuPebble can be used in a General Practice setting for moderate-to-severe OSA diagnosis.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jul 2023 31 Dec 2024

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39059802/ (added 29/07/2024)

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 to treatment through existing pathways.
We will compare the number of 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 moderate-to-severe OSA, it can be rolled out in primary care to improve the detection and treatment of OSA. Better detection would reduce risks, improve health and wellbeing; with fewer long-term health conditions.


Patients aged 50 -70 years with diabetes and/or high blood pressure and BMI over 30 kg/m².

You can take part if:



You may not be able to take part if:


1. Patients with known OSA2. Patients with known moderate-to-severe COPD3. Those deemed unable to take part by their GP (e.g. terminally ill)4. Patients with known allergy to acrylate


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of Warwick
    University House Gibbet Hill Road
    Coventry
    CV4 7AL

Participation will help us understand how best to identify people who may have OSA and protect their health for the long-term. From this trial we hope to find out whether using the hospital-based referral route (usual care) or the new GP-based route using the AcuPebble device (intervention) is most effective for the identification of OSA.
This trial uses a sleep study device that is already used in hospitals and will be used in line with its current approvals. Although there are no known serious risks associated with the device, some people using the device may experience mild discomfort. The control group will receive the usual care. Therefore, there are no known serious risks involved in taking part in this trial.
Most of the questionnaires we will use in this trial have been previously used in other studies and we do not expect these would cause any distress.

Dr Emma Scott
+44 24 7657 4654
e.j.scott@warwick.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Warwick and funded by NIHR Central Commissioning Facility (CCF).




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Read full details for Trial ID: ISRCTN16982033

Or CPMS 56660

Last updated 28 February 2025

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