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

Primary Purpose

Sleep Apnea Syndromes

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of pharyngeal critical airway closing pressure
Acoustic pharyngometry
Upper airway ultrasound
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Apnea Syndromes focused on measuring sleep apnea syndrome, upper airway, pCrit, acoustic pharyngometry, upper airway ultrasound

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Bichat-Claude Bernard

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspicion of sleep apnea syndrome

Arm Description

All patients, consulting Bichat sleep center for suspected sleep apnea syndrome

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

measure of pharyngeal volume by ultrasound
measure of pharyngeal collapsibility by ultrasound
predictive value (Sp, Se) of acoustic pharyngometry measurements
predictive value of ultrasound measurements (Sp, Se)
measure of apnea hypopnea index by polysomnography

Full Information

First Posted
February 22, 2023
Last Updated
August 1, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05774522
Brief Title
Study of Anatomo-functional Correlation of the Upper Airways
Acronym
P3E
Official Title
Study of Anatomo-functional Correlation of the Upper Airways
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
sleep apnea syndrome, upper airway, pCrit, acoustic pharyngometry, upper airway ultrasound

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suspicion of sleep apnea syndrome
Arm Type
Experimental
Arm Description
All patients, consulting Bichat sleep center for suspected sleep apnea syndrome
Intervention Type
Other
Intervention Name(s)
Measurement of pharyngeal critical airway closing pressure
Other Intervention Name(s)
pCrit
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Acoustic pharyngometry
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Upper airway ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
measure of the values of critical closing pressure of the upper airway
Time Frame
during procedure
Title
The measurements in cm of tissus thickness of the upper airways by ultrasound
Time Frame
during procedure
Title
measure the cross-sectional area of the upper airway by a acoustic pharyngometry
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
measure of pharyngeal volume by ultrasound
Time Frame
during procedure
Title
measure of pharyngeal collapsibility by ultrasound
Time Frame
during procedure
Title
predictive value (Sp, Se) of acoustic pharyngometry measurements
Time Frame
during procedure
Title
predictive value of ultrasound measurements (Sp, Se)
Time Frame
during procedure
Title
measure of apnea hypopnea index by polysomnography
Time Frame
during procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pia d'Ortho, MD. Ph.D
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris (AP-HP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of Anatomo-functional Correlation of the Upper Airways

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