Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis

Study Overview
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Brief Summary
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Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm, open-label, multicenter, national, controlled study.

Detailed Description
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The new Sunrise integrated digital solution is a disposable 3 gram sensor that sits on the chin for sleep disorders diagnosis. This device records mandibular movements, head movements and position during sleep. Data acquisition is done through a mobile application installed on the user smartphone. Data is then transferred automatically at the end of the test (overnight) to a cloud platform where it is automatically analyzed. The Health Care Professional (HCP) and the patient have access to sleep parameters and report. The objective of this trial is to determine the place of the Sunrise device in the care pathway in France for patients suspected of having OSA. The assumption is that Sunrise is both non-inferior to the normal practice (i.e., the PSG) on sleepiness at 3 months post-diagnosis, and superior to the PSG (outpatient or in-lab) in terms of time between inclusion and diagnosis appointment and treatment initiation. By speeding up the treatment initiation, the hypothesis is that Sunrise is also superior to the PSG on sleepiness as well as quality of life and work productivity at 3 months post-inclusion. Another assumption is that Sunrise is non-inferior to the PSG on CPAP compliance at 3 months following treatment initiation. The SUNSAS study will be launched in 19 centers (public and private) in France and will include 848 patients aged 18 to 80 years. Eligible patients will be included and randomized in 2 arms, i.e., the Sunrise arm and the PSG arm. An appointment to discuss the diagnosis and treatment options (for patients suffering from OSA) will be arranged after the procedure (PSG or Sunrise) is performed. On site follow-up visits will be then organized at 3 months post-inclusion and at 3 months post-diagnosis, and a phone call will be scheduled at 3 months post-treatment.

Official Title
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Validation d'Une Solution Digitale intégrée (SUNrise®) d'Analyse Automatique Des Mouvements Mandibulaires Par Intelligence Artificielle Versus Polysomnographie Pour le Diagnostic du Syndrome d'Apnées Obstructives du Sommeil

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Sunrise
* Device: polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Man or woman aged between 18 to 80 years old Patient referred for a suspicion of OSA Patient having a smartphone and internet connection at home and able to use a mobile application Patient affiliated to the social security system Main exclusion criteria: Patient with a previous sleep test performed within 5 years of inclusion Patient previously treated for OSA within 5 years of inclusion Patient suffering from severe chronic obstructive or restrictive pulmonary disease with or without oxygen at the discretion of the investigator Patient refusing to shave his beard that could prevent him to wear the device on the chin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Prospective, controlled, randomized, parrallel, open label, multicenter and national
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunrise<br>Home Sleep Test, OSA diagnosis based on mandibular movements recording | Device: Sunrise<br>* Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.<br>|
| Active Comparator: PSG<br>Polysomnography, OSA diagnosis based on local scoring by center | Device: polysomnography<br>* Reference protocol to diagnose OSA (in-lab or outpatient PSG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily sleepiness | To determine the non-inferiority of Sunrise vs PSG on sleepiness at 3 months post-diagnosis using the Epworth Sleepiness Scale (ESS) score. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher the average sleep propensity in daily life. | 3 months post-diagnosis | 
| Time to diagnosis | To determine the superiority of Sunrise vs PSG in terms of time between inclusion and diagnosis appointment | Up to 12 months | 
| Time to treatment | To determine the superiority of Sunrise vs PSG in terms of time between inclusion and treatment initiation | Up to 15 months | 
| Change in daily sleepiness | To determine the superiority of Sunrise vs PSG on sleepiness at 3 months post-inclusion using ESS | 3 months post inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | To determine the superiority of Sunrise vs PSG on quality of life at 3 months post-inclusion using Short Form 36 (SF-36) SF-36 is a 0-100 scale score, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 3 months post inclusion visit | 
| Change in quality of life | To determine the superiority of Sunrise vs PSG on quality of life at 3 months post-inclusion using Quebec Sleep Questionnaire (QSQ). QSQ utilizes 32 items to measure 5 domains: daytime sleepiness, diurnal symptoms, nocturnal symptoms, emotions, and social interactions.Item scores range from 1 to 7. Mean scores for each domain are calculated, and a total score is derived by calculating the mean of all items. Higher scores are associated with better better quality of life. | 3 months post inclusion visit | 
| Change in work productivity | To determine the superiority of Sunrise vs PSG on work productivity at 3 months post-inclusion using WPAI:SHP | 3 months post-inclusion | 
| cost (€)/QALY | cost (€)/QALY gained 3 months post-diagnosis | 3 months post-diagnosis | 
| Net profit for the French social security | Estimation of the net profit for the French social security at 3 years | estimated at 3 years | 
| Comparison of CPAP compliance data | To determine the non-inferiority of Sunrise vs PSG on CPAP compliance measured at 3 months post-treatment by comparing CPAP average usage in both groups | 3 month after treatment initiation | 
| Comparison of Sunrise versus PSG diagnosis | To confirm the diagnosis performance of Sunrise compared to PSG by comparing the obstructive respiratory disturbance index (ORDI) in both groups | Up to 12 months | 
| Difference in the obstructive respiratory disturbance index (ORDI) | To measure the variability of the ORDI by comparing the 3 obstructive respiratory disturbance index (ORDI) measures provided by the Sunrise device (used 3 nights) | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polysomnography, obstructive sleep apnea, home sleep test, artificial intelligence, mandibular movement