Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome

Study Overview
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Brief Summary
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This prospective study aims to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.

Detailed Description
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Polysomnography is the gold-standard for obstructive sleep apnea (OSA) diagnosis. However, OSA is still undiagnosed. Maxillofacial profile can influence OSA severity. Morphological characteristics can be identified but are not enough measurable and analysable by physicians. 3D acquisition of maxillofacial characteristics with a user-friendly tool, quick and low-priced could be used to obtain a predictive model as an OSA risk indicator. Thus, the aim of this study is to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.

Official Title
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Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Diagnostic Test: 3D acquisition of maxillofacial characteristics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI < 35 kg/m² caucasian men patients from the sleep laboratory (CHU Grenoble Alpes) admitted for a polysomnography Patient who has given free and informed consent in writing Exclusion Criteria: history of maxillofacial surgery dental malocclusion patient involved in another clinical research study patient not affiliated with social security patient deprived of liberty or hospitalized without consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OSA diagnosis with 3D acquisition<br>OSA diagnosis with 3D acquisition | Diagnostic Test: 3D acquisition of maxillofacial characteristics<br>* A 3D acquisition of maxillofacial characteristics will be performed for each patient in order to validate a predictive model comparable to data obtained by polysomnography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish and evaluate a predictive model for OSA diagnosis by 3D acquisition of characteristics maxillofacial | apnea hypopnea index will be measured by polysomnography for each patient and compared to a predictive model establish from body mass index and 3D acquisition (cricomental distance...) | 1 measure at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity study from different stages of OSA severity | OSA severity stages will be apnea hypopnea index <5, <10, <15 | 1 measure at inclusion | 
| Compare diagnosis performances of predictive model and Berlin or NoSAS questionnaires | Correlation between the Berlin or NoSAS score and the predictive model results | 1 measure at inclusion | 
| Evaluate performances of the combination (Berlin questionnaire + predictive model) to estimate the OSA risk | Calculate the sensitivity, specificity, predictive positive value and predictive negative value of the combination | 1 measure at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea diagnosis, 3D acquisition