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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Diagnostic Test: 3D acquisition of maxillofacial characteristics

Study type

Interventional

Funder types

Other

Identifiers

NCT03632382
38RC17.359

Details and patient eligibility

About

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

Full description

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.

Enrollment

280 patients

Sex

Male

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

280 participants in 1 patient group

OSA diagnosis with 3D acquisition
Other group
Description:
OSA diagnosis with 3D acquisition
Treatment:
Diagnostic Test: 3D acquisition of maxillofacial characteristics

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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