The SOSAT Trial
Research type
Research Study
Full title
A prospective, multicentre, randomised, blinded study of obstructive sleep apnoea detection using the Sunrise solution: The Sunrise OSA Trial (SOSAT)
IRAS ID
296444
Contact name
Julia L Kelly
Contact email
Sponsor organisation
Royal Brompton Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
Obstructive Sleep Apnoea (OSA) occurs when the muscles in the throat relax during sleep which leads to narrowing or closing of the patient airway resulting in a drop in oxygen level and then an awakening from sleep. This happens repetitively throughout every hour of sleep and can lead to poor sleep and daytime symptoms. Therefore, undiagnosed and untreated OSA can lead to unrestful sleep and disabling symptoms including excessive daytime sleepiness, fatigue, irritability, difficulty concentrating and poor memory, and other serious medical consequences.
Although OSA affects approximately 1.5 million adults in the UK, up to 85% are undiagnosed, and therefore untreated.
OSA treatment by continuous positive airway pressure therapy (CPAP) has been shown to be cost-effective in relieving OSA symptoms and improving patients' quality of life. However, there is still a mismatch between predicted regional healthcare requirements and the availability of clinical sleep services. This has resulted in reduced service provision in some areas making patients undergoing investigation for OSA wait longer (14 months in certain hotspots) to access care.
Therefore, this study aims to determine whether a novel diagnostic solution using the Sunrise device, compared to standard home overnight polygraphy, can reduce time to treatment decision in patients referred for investigation of suspected OSA. We also want to evaluate time to treatment decision in the Scottish Highlands and Islands compared to Inner London. Additionally, we want to determine the patient experience throughout the clinical care pathway for the diagnosis of OSA comparing the use of the Sunrise solution and home polygraphy.
Patients under investigation for OSA will use both devices simultaneously for a single overnight sleep study. They will be randomised to receive their treatment decision based on either the Sunrise solution or polygraphy. Questionnaires will assess the patient experience.
Summary of Results
Obstructive sleep apnoea is a common breathing disorder that happens during sleep, in which the upper airway becomes blocked, causing pauses in breathing. This can lead to poor sleep and symptoms such as daytime sleepiness. Many patients with obstructive sleep apnoea have not had the condition identified and are not getting treatment for it. One reason for this is because sleep services have long waiting times for patients who need a sleep test.
Standard sleep tests devices require professionals’ time to set-up, download and prepare sleep test results for the treating doctor. Newly developed sleep testing devices could make the diagnosis of obstructive sleep apnoea faster. One of these devices, is a small sensor that sticks on the chin to measure jaw movement and uses automatic analysis for the sleep test results.
Patients who were waiting for a sleep test to help diagnose obstructive sleep apnoea were asked to take part in this study; 40 patients from Northern Scotland and inner London completed the study. Each patient used two home sleep testing devices on the same night; one standard test device called a ‘respiratory polygraphy’ and one new test device called a ‘jaw movement monitor’. We measured how long it took for each patient to get a decision about their diagnosis and treatment from the treating doctor. Half of the patients got their decision based on the new device's results, and the other half of the patients had their decision based on the standard sleep test results.
We found that when the new test device was used to make a treatment decision, it was nearly a week faster than when the standard sleep test was used. The new test device also saved clinical time for healthcare professionals; approximately half an hour per patient. There was no difference in the time to treatment decision for patients in Northern Scotland, compared to those in inner London.
These results suggest that the new test device, a jaw movement monitor with automated analysis of results, is a faster way to diagnose obstructive sleep apnoea, compared to standard sleep testing.
REC name
Wales REC 3
REC reference
21/WA/0162
Date of REC Opinion
21 May 2021
REC opinion
Favourable Opinion