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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: 3D acquisition of maxillofacial characteristics

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Grenoble Alpes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: OSA diagnosis with 3D acquisition	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: SATT Linksium GRENOBLE; ARTEHIS; ARCTIC
• Investigators: Principal Investigator: Jean-Louis PEPIN, Chu Grenoble Alpes

Publications and helpful links

General Publications

• Monna F, Ben Messaoud R, Navarro N, Baillieul S, Sanchez L, Loiodice C, Tamisier R, Joyeux-Faure M, Pepin JL. Machine learning and geometric morphometrics to predict obstructive sleep apnea from 3D craniofacial scans. Sleep Med. 2022 Jul;95:76-83. doi: 10.1016/j.sleep.2022.04.019. Epub 2022 Apr 29.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Actual): July 27, 2018
• Study Completion (Actual): September 8, 2020

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Sleep apnea diagnosis; 3D acquisition
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 38RC17.359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No