NCT03632382

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2018-07-27
• Primary completion: 2018-07-27
• Completion: 2020-09-08
• First posted: 2018-08-15
• Last updated: 2021-02-10

Locations

1 site across 1 country: France