Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05774522 |
| Other study ID # |
APHP220939 |
| Secondary ID |
2022-A01754-39 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 7, 2023 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 apnea/hypopnea
(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.
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.
