The Sunrise OSA Trial

Study Overview
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Brief Summary
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A prospective, randomised, blinded pilot study comparing the Sunrise solution and overnight polygraphy for the diagnosis of OSA in adult patients. 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. A retrospective check of their diagnosis will be done.

Official Title
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A Prospective, Multicentre, Randomised, Blinded Study of Obstructive Sleep Apnoea Detection Using the Sunrise Solution

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Sunrise
* Device: Polygraphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 Ability and willingness to provide informed consent Patient referred for suspected OSA BMI >28 kg/m2 Epworth Sleepiness Score >12 Reported snoring (criterion may be ignored if patient sleeps alone) Patient able to use a smartphone application and having an internet connection at home Exclusion Criteria: Patient already treated for OSA Patient has PSV or HGV driving license Unstable cardiac disease Supplemental oxygen Known secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome Concerns about sleepy driving or any other potentially dangerous symptom from physician or urgent referral from GP when patient has been told to stop driving Pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure Patient whose beard is too thick to wear the Sunrise device, and who does not wish to shave Patient with acrylic or painted fingernails, who does not wish to remove acrylic or paint

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, randomised, blinded pilot study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunrise<br>Participants under investigation for OSA will use both devices (Sunrise solution and overnight polygraphy) simultaneously for a single overnight sleep study. Participants randomised to the 'Sunrise' arm will receive their treatment decision based on the Sunrise solution. | Device: Sunrise<br>* Sunrise (Sunrise SA, Belgium) is a novel integrated digital medicine solution for the diagnosis of OSA allowing the detection of respiratory disorders from the analysis of mandibular movements optimised by an artificial intelligence algorithm machine learning. It is composed of a unique innovative sensor, placed on the chin during the night, connected via Bluetooth to a mobile application which guides the patients for the implementation and allows the transfer of the data collected by the sensor to a certified health host guaranteeing the security and confidentiality of medical data. The analysed data is integrated and automatically transferred into a detailed report made available to doctors via a secure website the day after the test.<br>|
| Active Comparator: Polygraphy<br>Participants under investigation for OSA will use both devices (Sunrise solution and overnight polygraphy) simultaneously for a single overnight sleep study. Participants randomised to the 'polygraphy' arm will receive their treatment decision based on the polygraphy. | Device: Polygraphy<br>* Polygraphy (Apnoealink-Air, ResMed, Australia) is a commercially available, limited-channel sleep study device which can be used in the home. Many sleep services in the UK already use the ApneaLink Air for routine screening. It is a portable device which consists of a nasal cannula to measure nasal flow and snoring, oximeter to measure pulse and blood oxygen levels, and a chest band to measure respiratory effort. It contains software which allows for the scoring of apnoeas, hypopnoea and arousals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment decision | Time (days) from sleep study device dispatch to treatment decision | From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment decision; RBH vs NHS Scotland Sleep Service | Time (days) from sleep study device dispatch to treatment decision; inner London (Royal Brompton hospital) vs Scottish Highlands (NHS Scotland Sleep Service) | From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months | 
| AHI | Apnoea-hypopnoea index compared between sleep study devices; Sunrise and polygraphy | After completion of the sleep studies and data from both devices is available; typically within 1 month but up to 6 months |