Study of Anatomo-functional Correlation of the Upper Airways

NCT05774522 | Unknown

• 2 other identifiers: APHP2209392022-A01754-39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Keywords

sleep apnea syndrome; upper airway; pCrit; acoustic pharyngometry; upper airway ultrasound

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

Suspicion of sleep apnea syndrome

EXPERIMENTAL

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

Other: Measurement of pharyngeal critical airway closing pressure; Other: Acoustic pharyngometry; Other: Upper airway ultrasound

Interventions

Measurement of pharyngeal critical airway closing pressure OTHER

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.

Also known as: pCrit

Suspicion of sleep apnea syndrome

Acoustic pharyngometry OTHER

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.

Suspicion of sleep apnea syndrome

Upper airway ultrasound OTHER

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.

Suspicion of sleep apnea syndrome

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient for whom an PSG are prescribed as part of care

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marie-Pia d'Ortho, MD. Ph.D

  Assistance Publique - Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 17, 2023
• Study Start: February 7, 2023
• Primary Completion: July 31, 2023
• Study Completion: September 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

FR (1)