Study of Anatomo-functional Correlation of the Upper Airways

NCT05774522 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-08-03

No results posted yet for this study

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.

Conditions

  • Sleep Apnea Syndromes

Interventions

OTHER

Measurement of pharyngeal critical airway closing pressure

The Pcrit will be measured on an automatic controlled device specially designed by the engineers of the inserm neophen team capable of varying the pressures from +4 to -20 centimeters of water, by a nasal mask whose pressures are connected to a pneumotachograph. The measurements will be performed in supine position.

OTHER

Acoustic pharyngometry

Acoustic pharyngometry is an non-invasive technique consisting of the propagation of an acoustic wave from the lips to the larynx providing information on the lengths, cross-sectional areas and volumes of the air spaces.

OTHER

Upper airway ultrasound

Airway ultrasound is a non-invasive imaging allowing visualization and measurements of the tongue base and retrovascular fatty infiltration. Its main interest remains the evaluation of the tongue base which is clinically difficult.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marie-Pia d'Ortho, MD. Ph.D · Assistance Publique - Hôpitaux de Paris (AP-HP)

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2023-07-31
Completion
2024-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774522 on ClinicalTrials.gov