Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

Study Overview
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Brief Summary
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Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis. The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.

Detailed Description
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Sunrise® is a type IIa medical device with the CE label. It is a new home sleep technology, non-invasive, reliable and affordable by the patient. The objective of this study is to evaluate the efficiency of the device in comparison with PSG for sleep apnea diagnosis. 40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution will provide the respiratory event index (REI) as well as the respiratory micro-arousals. Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.

Official Title
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Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis

Conditions
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Sleep Apnea Syndrome, Obstructive

Intervention / Treatment
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* Diagnostic Test: Sunrise® solution
* Diagnostic Test: Polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suspected to have a sleep apnea syndrome (Berlin score≥2) Able to use a smartphone application Be legally able to give consent Person affiliated to social security Exclusion Criteria: Patients already treated for SAS Patients suffering from a chronic obstructive or restrictive pulmonary disease with or without oxygen. Patients suffering from a unstable cardiovascular disease or a severe heart failure requiring an hospitalzation in the previous three months or conform with the New York Heart Association criteria for class II or III diseases Patients treated with myorelaxant medicines Patients with a long beard disabling the setting of the mandibular sensor Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act. Person in exclusion period for another study or participating in a medical study testing drugs. Subjects not being cooperative or respecting the study instructions, according the investigator.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunrise+PSG<br>PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights. | Diagnostic Test: Sunrise® solution<br>* Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.<br>Diagnostic Test: Polysomnography<br>* Gold standard method to diagnose SAS used as comparator<br>* Other names: PSG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The performance of Sunrise® to detect the respiratory event index (REI) | Evaluation of the correlation between Sunrise® and PSG for the estimation of the REI | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Sunrise® reproductibility on three consecutive nights | REI measured by Sunrise® on three consecutive nights | 3 nights | 
| Evaluation of the sleep quality: depth of sleep | Depth of sleep was assessed by the St Mary Hospital Questionnaire Q1 (scale from 1 very light to 8 very depth), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only | 3 nights | 
| Evaluation of the sleep quality: number of wake-ups | Number of Wake-ups was assessed by the St Mary Hospital Questionnaire Q2 (scale from 0 no Wake-up to 7 more than 6 Wake-ups), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only | 3 nights | 
| Evaluation of the sleep quality: sleep duration | Sleep duration was assessed by the St Mary Hospital Questionnaire Q3 (in hour), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only | 3 nights | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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New medical device, Mandibular movement, Respiratory event index, Polysomnography