Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774522
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-03
First Post:
2023-02-22
Brief Title:
Study of Anatomo-functional Correlation of the Upper Airways
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of Anatomo-functional Correlation of the Upper Airways
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
P3E
Brief Summary:
Sleep apnea-hypopnea syndrome SAHS is a disorder of nocturnal ventilation due to the occurrence abnormally frequent pauses in breathing It is a public health problem that currently affects 13 of men and 6 of women between 30 and 70 years old Sleep apneas are conventionally divided into obstructive and central apneas depending on the persistence or no respiratory movements and the existence or not pharyngeal collapse during apnea There are upper airway characterization studies VAS in patients with syndrome sleep apneahypopnea OSAS These physiological characterization studies measurement of critical closing pressure Pcrit of the VAS and anatomical transcutaneous ultrasound of the muscles of the floor of the mouth the base of the tongue or by a acoustic pharyngometry of the VAS are interested separately to different parameters without searching correlation with the severity of sleep apnea nor their potential as a screening tool for OSAS in patients at risk The investigators hypothesize that a strong correlation and constant exists between the physiological collapsibility of VAS the anatomical measurements of the VAS and the degree of severity of OSAS Thus the aim of this descriptive study is to characterization as complete as possible of the VAS of apneic patients in a homogeneous population and a better understanding of the pathophysiological obstructive events in patients without factor obvious risk
Detailed Description:
Obstructive sleep apnea-hypopnea syndrome OSAS is a nocturnal respiratory disorder caused by a succession of respiratory pauses The prevalence of OSAHS has increased over the past two decades partly due to the fact that it is more often diagnosed but also due to the progression of obesity It now affects 13 of men and 6 of women between the ages of 30 and 70 Sleep apneas are conventionally divided into obstructive and central apneas depending on whether or not respiratory movements persist and whether or not there is pharyngeal collapse during the apnea Continuous positive airway pressure CPAP ventilation via a nasal or naso-buccal mask is the reference treatment The effectiveness of CPAP is directly linked to its observance A well conducted treatment allows a significant improvement of symptoms related to OSAHS and effectively reduces daytime sleepiness In the longer term it would provide protection against cardiovascular events
The physiopathology of obstructive apnea has been the subject of in-depth studies the most recent data show that it is a multifactorial disease Among the factors implicated the investigators can cite pharyngeal anomalies anatomy and collapsibility a significant ventilatory response high loop gain in response to variations in partial pressure of CO2 pCO2 a weak pharyngeal muscle response during sleep and a high wakefulness threshold Each of them can be evaluated by different methods anatomy by a standardized clinical examination and imaging techniques some of which have not yet been the subject of anatomo-functional correlation studies such as the ultrasound or acoustic pharyngometry collapsibility by measuring the critical closure pressure Pcrit pressure applied at which closure of the airways is observed the ventilatory response by analysis of the SpO2 and PCO2 signals in the exhaled air PETCO2 in calm ventilation and ventilatory slope of response to hypercapnia pharyngeal electromyogram and polysomnographic analysis
The respective importance of these factors seems to vary greatly from one individual to another but their characterization would make it possible to propose new avenues of treatment targeting the loop gain the pharyngeal muscle tone or the arousal threshold and d adapt these targets to each patient for a personalized treatment
The investigators hypothesize that a correlation exists between the physiological collapsibility of the VAS the anatomical measurements of the VAS and the degree of severity of OSAHS The objectives of our study are to identify clinical and physiological phenotypes of apneic patients with the prospect of screening tools a better distribution of targeted diagnostic and therapeutic resources
The physiopathology of obstructive apnea has been the subject of in-depth studies the most recent data show that it is a multifactorial disease Among the factors implicated the investigators can cite pharyngeal anomalies anatomy and collapsibility a significant ventilatory response high loop gain in response to variations in partial pressure of CO2 pCO2 a weak pharyngeal muscle response during sleep and a high wakefulness threshold Each of them can be evaluated by different methods anatomy by a standardized clinical examination and imaging techniques some of which have not yet been the subject of anatomo-functional correlation studies such as the ultrasound or acoustic pharyngometry collapsibility by measuring the critical closure pressure Pcrit pressure applied at which closure of the airways is observed the ventilatory response by analysis of the SpO2 and PCO2 signals in the exhaled air PETCO2 in calm ventilation and ventilatory slope of response to hypercapnia pharyngeal electromyogram and polysomnographic analysis
The respective importance of these factors seems to vary greatly from one individual to another but their characterization would make it possible to propose new avenues of treatment targeting the loop gain the pharyngeal muscle tone or the arousal threshold and d adapt these targets to each patient for a personalized treatment
The investigators hypothesize that a correlation exists between the physiological collapsibility of the VAS the anatomical measurements of the VAS and the degree of severity of OSAHS The objectives of our study are to identify clinical and physiological phenotypes of apneic patients with the prospect of screening tools a better distribution of targeted diagnostic and therapeutic resources
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01754-39 | OTHER | EUDRACT | None |