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| Name | Class |
|---|---|
| Sunrise | INDUSTRY |
| Icadom | INDUSTRY |
| DOCAPOST | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunrise+PSG | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunrise® solution | Diagnostic Test | Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Louis Pépin, MD, PhD | University Hospital Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble Alpes | Grenoble | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35368281 | Derived | Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Polysomnography | Diagnostic Test | Gold standard method to diagnose SAS used as comparator |
|
|
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |