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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2020-09-08

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.

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OSA diagnosis with 3D acquisition

Group Type OTHER

3D acquisition of maxillofacial characteristics

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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3D acquisition of maxillofacial characteristics

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

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes