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

Obstructive Sleep Apnea Clinical Trial

— Episas  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632382
• Other study ID #: 38RC17.359
• Status: Completed
• Phase: N/A
• Start date: July 27, 2018
• Est. completion date: September 8, 2020

Study information

• Verified date: February 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 8, 2020
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Grenoble Alpes University Hospital	Grenoble

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	ARCTIC, ARTEHIS, SATT Linksium GRENOBLE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity study from different stages of OSA severity	OSA severity stages will be apnea hypopnea index <5, <10, <15	1 measure at inclusion
Secondary	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
Secondary	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