Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-29 @ 6:58 PM
Study NCT ID:
NCT05808868
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2023-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identify Patients at Risk of Moderate or Severe OSA During ENT Examination
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Identify Patients at Risk of Moderate or Severe OSA During ENT Examination
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The management of OSA is multidisciplinary. Today, there are many self-evaluation questionnaires aiming at predicting or evaluating the severity of OSA. However, no clinical score takes into account the specificities of the ENT clinical examination, which is a major actor in the management of the disease. The aim of this study is to create a clinical score predictive of the diagnosis and severity of OSA, using already published data, completed with the specificities of the ENT clinical examination.
Detailed Description:
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is defined as an alteration in nocturnal ventilation related to partial or complete collapse of the upper aerodigestive tract (UAD). The pharyngeal collapse responsible for nocturnal respiratory abnormalities is explained by three factors: anatomical narrowing of the upper airway, increased pharyngeal compliance and loss of efficiency of the pharyngeal dilator muscles. The prevalence of OSA has been estimated to be between 9% and 38%. However, OSA remains under-diagnosed. This syndrome leads, in the absence of treatment, to an overall excess mortality, particularly cardiovascular, and to numerous cardio-metabolic, neurological, psycho-social and road accident complications. Therefore, the identification of patients at risk of OSA through early and targeted screening becomes a public health issue in order to implement an effective treatment to reduce these complications.
VADS examination coupled with nasofibroscopy is a routine examination in ENT consultation. This examination can help to identify patients at risk of OSA and allow its pre-therapeutic evaluation, in order to define the patient's profile and personalize its management. The sites of VADS collapse are multiple. A systematic review on drug induced sleep endoscopy (DISE) found a distribution of obstructive sites of 58.8% for the soft palate, 43.2% for the base of the tongue, 29.9% for the lateral walls of the pharynx and 22.4% for the epiglottis. However, the laryngeal stage also plays a major role in the mechanism of OSA. Endoscopy under induced or natural sleep is a reliable method to identify obstructive sites. However, these techniques require important means (access to the operating room, dedicated hospital room), time, specific equipment and qualified personnel.
The standardized ENT clinical examination coupled with nasofibroscopy is inexpensive, rapid and easily accessible. It allows to identify patients at risk of OSA, to specify the obstructive sites in the VADS and to optimize the therapeutic management by differentiating the patients' profiles.
The objective of this study was to identify anatomical factors predictive of moderate/severe OSA on routine ENT examination in awake patients.
VADS examination coupled with nasofibroscopy is a routine examination in ENT consultation. This examination can help to identify patients at risk of OSA and allow its pre-therapeutic evaluation, in order to define the patient's profile and personalize its management. The sites of VADS collapse are multiple. A systematic review on drug induced sleep endoscopy (DISE) found a distribution of obstructive sites of 58.8% for the soft palate, 43.2% for the base of the tongue, 29.9% for the lateral walls of the pharynx and 22.4% for the epiglottis. However, the laryngeal stage also plays a major role in the mechanism of OSA. Endoscopy under induced or natural sleep is a reliable method to identify obstructive sites. However, these techniques require important means (access to the operating room, dedicated hospital room), time, specific equipment and qualified personnel.
The standardized ENT clinical examination coupled with nasofibroscopy is inexpensive, rapid and easily accessible. It allows to identify patients at risk of OSA, to specify the obstructive sites in the VADS and to optimize the therapeutic management by differentiating the patients' profiles.
The objective of this study was to identify anatomical factors predictive of moderate/severe OSA on routine ENT examination in awake patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: