Study of Anatomo-functional Correlation of the Upper Airways (P3E)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Other: Measurement of pharyngeal critical airway closing pressure; Other: Acoustic pharyngometry; Other: Upper airway ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Pia d'Ortho, MD. PhD; Phone Number: +33 1 402 58401; Email: marie-pia.dortho@aphp.fr
• Study Contact Backup: Name: Justine Frija-Masson, MD; Phone Number: +33 01 40 25 84 01; Email: justine.frija@aphp.fr

Study Locations

• France
  • Paris, France, 75018
    • Hopital Bichat-Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria: - Any patient, consulting the sleep department of the Bichat hospital for suspected sleep apnea syndrome

• Patient for whom an PSG are prescribed as part of care
• Age ≥18 years and ≤85 years Exclusion criteria: - Recent ENT surgery (less than 6 months)
• Pregnancy in progress (declared)
• Pulsed oxyhaemoglobin saturation < 88% at rest on awakening
• Allergy to ultrasound gel
• Patient with difficulties in understanding the French language
• Vulnerable patient (guardianship, curators)
• Lack of affiliation to a social security scheme
• Lack of information and collection of informed, written and signed consent
• Patient under AME

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Suspicion of sleep apnea syndrome; All patients, consulting Bichat sleep center for suspected sleep apnea syndrome

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 Names: pCrit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measure of the values of critical closing pressure of the upper airway	during procedure
The measurements in cm of tissus thickness of the upper airways by ultrasound	during procedure
measure the cross-sectional area of the upper airway by a acoustic pharyngometry	during procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
measure of pharyngeal volume by ultrasound	during procedure
measure of pharyngeal collapsibility by ultrasound	during procedure
predictive value (Sp, Se) of acoustic pharyngometry measurements	during procedure
predictive value of ultrasound measurements (Sp, Se)	during procedure
measure of apnea hypopnea index by polysomnography	during procedure

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Marie-Pia d'Ortho, MD. Ph.D, Assistance Publique - Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: sleep apnea syndrome; upper airway; pCrit; acoustic pharyngometry; upper airway ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: APHP220939; 2022-A01754-39 (Other Identifier: EUDRACT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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