Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of the Air Flow Through Airways, a Randomized Controlled Study
Conditions: Obstructive Sleep Apnea, OSA
Sponsor: Center for Sleep Medicine - Clinique André Renard

id: OSASSS1 - NCT:06092710
Predictability of OSA with a Subjective Screening Scale
Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of the Air Flow Through Airways, a Randomized 
Controlled Study
Mai 11, 2025

About the study protocole: 
The oropharynx, due to its speciﬁc layout in humans, is unstable under the eﬀect of inspiratory 
depression during ventilation. Continuous control of the oropharyngeal lumen is necessary to 
ensure optimal ventilation. 
The combined role of all the pharyngeal dilator muscles and the muscles constituting the 
pharyngeal groove is essential for maintaining the patency of the pharyngeal upper airway. The 
action of these muscles allows for the postural adjustment of the pharyngeal cavities and the 
rigidity of the entire pharyngeal muscular groove. 
The permeability of the upper airways is therefore largely dependent on optimal tone of the 
muscles constituting the walls of the upper airways. The management of the tone of these 
muscles is possible thanks to the numerous mechanosensory receptors present in the upper 
airways. There are many of them, among which some are sensitive to changes in shape, the 
passage of air, variations in temperature, pressure, etc. The opening reﬂex of the upper airways 
depends on the integrity and quality of these receptors. Several known factors can lead to an 
alteration of these receptors: vibrations of the soft palate, edema, inﬂammation, hypoxia, GERD, 
drying of the mucous membranes, postnasal drip, etc. 
In sleep disorders, the excitability threshold of these receptors can vary depending on the extent 
of VAS resistance (SRAVAS), or even collapse (OSA). It is possible that the sensitivity of these 
receptors is exacerbated in cases of SRAVAS and mild OSA and reduced or even inhibited in 
severe forms of OSA. 
Numerous parietal factors modify the volume and permeability of the pharynx (pharyngeal lumen) 
and act through diﬀerent mechanisms: 
- Modiﬁcation of the pharyngeal lumen in the transverse and sagittal dimensions 
- Modiﬁcation of transmural parietal tension (longitudinal tension) and therefore of the compliance 
of the pharyngeal wall by the passive and active tension of the pharyngeal muscles (tonic, phasic) 
Considering the permeability of the pharynx, we can identify biomechanical parameters that 
increase resistance to the passage of air in the upper airways (aggravating parameters) and others 
that decrease resistance (facilitating parameters). 
Aggravating factors: 
- Supine position 
- Altered state of consciousness (ﬁrst sleep stage) 
- Mouth breathing and loss of lingual-palatal and labial-labial contact 
- Passive craniocervical ﬂexion 
Facilitating parameters: 
- Cephalocervical extension 
- Mandibular advancement 
- Tongue protraction 
- Eﬃcient nasal ventilation 
These considerations allow us to establish an examination protocol to attempt to answer the 
following questions: 
- Can the subject consciously perceive variations in airﬂow/or intraluminal pressure in the upper 
airways caused by the various aggravating and facilitating parameters? 
- Can the sensations of ventilatory ﬂow/intraluminal pressure felt by the subject constitute a 
complementary tool for screening for obstructive sleep disorders? 
The goal of the clinical examination is to cause instability of the oropharyngeal mechanics. This 
instability can cause a modiﬁcation of the pharyngeal lumen and a modiﬁcation of the resistance 
of the VAS to the pressure linked to the ventilatory ﬂow. These will lead to a modiﬁcation of the 
inspiratory pressure gradient and stimulate the mechanoreceptors located in the VAS. The 
responses to a questionnaire by subjects who present sleep disorders exposed to these variations 
in resistance (aggravating or facilitating) on their subjective feeling allows the establishment of a 
perception scale which, compared to a control group without sleep disorders, will determine if the 
sensitivity of the inputs is comparable between the groups and if a tool for screening sensory 
inputs is possible. 

Protocol: 
The questionnaires to assess patients' pharyngeal ventilatory perceptual potential/the quality of 
spontaneous nasopharyngeal perception during ventilation are administered when patients come 
to the consultation to request the results of the pharyngeal ventilatory perceptual analysis. The 
examiners are blinded, unaware of the results. Patients are randomly assigned according to their 
order of arrival. The ﬁrst questionnaire consists of 7 items selected to aggravate or facilitate upper 
airways permability (supine position, modiﬁed state of consciousness with muscle relaxation, 
tongue posture, cephalic ﬂexion, cephalic extension, mandibular protraction, nostrils aperture). 
This ﬁrst questionnaire try to evaluate if all subjects are able to feel aggravating or facilitating 
factors by on/oﬀ answers. The second questionnaire consists of 18 items related to upper airway 
collapsibility. Each item concerns the aggravating or facilitating factors perceived by the patient or 
the therapist with clinical maneuvers, factors known to be unfavourable to the permeability of the 
upper airways (snoring, oral ventilation, tonsils, dento-skeletal class, etc.), as well as two 
questionnaires used in the sleep laboratory of the André Renard clinic (Epworth Sleepiness Scale 
and FFF questionnaire). 
For each of these items, the patient's or practitioner's response will be noted. 
Performing the examination: 
- Sensory-motor awareness of nasal and pharyngeal breathing (patient in a seated position): 
explain to the patient what to observe and feel and where (soft palate, tonsils, vibration during 
snoring, etc.) 
- Read the questionnaire to the patient: it must be understood 
- Ask the patient to answer each item and record the response. 
The examination lasts approximately 20 minutes. 
This examination requires patient involvement but carries no risks or side eﬀects. 

 N≥55 subjects with PSG, Epworth, Pichot, FFF scales ==> SAOS validated and severity stage determined
N≥55 subjects after Epworth, Pichot, Berlin, FFF scales ==> negativity of SAOS
 N= « x »  subjects with SAOS
 N≥ (110 -  x)   subjects without SAOS
Randomized by 3 neurologists from Clinique André Renard
Subjective sensitivity protocol by 2 « blinded » manual therapist 
N≥110
recruitment
inclusion
primary outcomes: Does the clinical screening tool based 
on a score using the subjective perception of airway 
collapsibility make it possible to identify subjects with OSA 
and subjects without OSA?
secondary outcomes: Is it possible to predict the 
severity of OSA according to the score obtained by the 
clinical screening tool using the subjective perception 
of upper airway collapse?
primary outcomes: Do clinic patients and controls 
perceive the expected variations in aggravating 
and facilitating maneuvers?
Subjective screening protocol by 2 « blinded » manual therapist 
if no = end of the study
if no = end of the study
N≥110
N≥ « X »
if no = end of the study
secondary outcomes: Is it possible to determine 
indications for therapeutic tools based on items 
assessed during clinical screening using the subjective 
sensitivity of upper airway collapsibility?
N≥ « X »

STATISTATICAL ANALYSIS PLAN 
(translation of the Statistical analysis report download in SAP section from an independent 
Biostatistician: Laurent Massart, MyStat.be) 
Software used for analysis: R version 4.4.1(R Core Team (2024). R: A language and environment for 
statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-
project.org/) and Microsoft Excel for manipulating and preparing the data tables. data ﬁles used and 
appended: d1_ﬁnal.csv, d2_ﬁnal.csv 
1 - d1_ﬁnal.csv: sensitivity parameters taken from 112 patients 
2 - d2_ﬁnal.csv: parameters taken from 101 patients (excluding CHR patients considered normal after 
polysomnography) 
Discrete variables for classiﬁcation into groups : 
- STATUS3: 2 categories: healthy patients (= non-CHR control patients and normal CHR patients) and 
pathological patients (= CHR patients aﬀected to varying degrees) 
- STATUS4: 4 categories: control patients (= non CHR), normal patients (= CHR N), mild symptom patients 
(= CHR SL), moderate symptom patients (= CHR SM) and severe symptom patients (= CHR SS). 
A. Descriptive statistics (based on ﬁle n°1 - sensitivity)  
B. Descriptive statistics (based on ﬁle n° 2 - predictive score)  
C. Normality tests for intermediate and ﬁnal scores   
- Parameter ST1 (SubTotal1) = aggravating parameters 
Shapiro-Wilk normality test 
- Parameter ST2 (SubTotal2) = facilitating parameters 
Shapiro-Wilk normality test 
- Parameter ST1+ST2 (SubTotal1+ SubTotal2) = subjective sensitivity of patients 
Shapiro-Wilk normality test 
- Parameter ISF (Intermediate Final Score) = subjective sensitivity of patients and practitioner 
Shapiro-Wilk normality test 
- Parameter TFS (Total Final Score) = subjective sensitivity of patients and practitioner + valuable factors 
Shapiro-Wilk normality test 
D. Spearman correlation tests between ﬁnal scores and certain variables 
E. Non-parametric tests on patient sensitivity : 
Given the non-normal distribution of the various variables other than IFS and TFS, non-parametric tests 
(based on the median of the data) were applied to analyse the diﬀerences between the groups (according to 
the STATUS3 and STATUS4 classiﬁcation criteria). To analyse any diﬀerences in sensitivity between patient 
groups, Kruskal-Wallis tests were applied. In this type of analysis, having a p-value greater than 1% and 
ideally greater than 5% would indicate the absence of diﬀerences between groups. 
Then, to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the 
diﬀerences in airﬂow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed 
on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that 
the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the 
diﬀerences in airﬂow depending on their position. This is the case for all the patient groups tested on ST1, 
ST2 and ST1+ST2. 
F. Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): 
For these analyses, as the IFS and TFS scores follow a normal distribution, ANOVAs (analyses of variance) 
were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 
comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another. 
Signiﬁcant values are highlighted in bold red. 
G. Determination of cut-oﬀ values for IFS and TFS: 
The Cutoﬀ_ﬁnal txt ﬁle includes the various sensitivity and speciﬁcity calculations as well as the Youden 
index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the 
ﬁle to be appreciated graphically.

Assessment of oro-pharyngeal sensitivity
Date : 
Name:
age: 
Tests
   Items
Score
1
0
Aggravation maneuver 
1
Supine position
Aggravation maneuver 
2
Modified state of consciousness (overall relaxation) 
Aggravation maneuver 
3
Cephalic Flexion 
Aggravation or Facilitation maneuver 
4
Upper-anterior tongue to lower tongue (= aggravation) or 
lower tongue to upper-anterior tongue (= facilitation)
Facilitation maneuver 
5
Cephalic Extension
Facilitation maneuver 
6
Mandibular protrusion
Facilitation maneuver 
7
Nostrils aperture 
Total Score
… / 7
Comments :
Aggravation or facilitation felt= 1
No aggravation or no facilitation felt= 0
www.osteovox.be

Upper rhino-oro-pharyngeal airway permeability - Subjective neuro-sensory evaluation 
Date : 
Name :
age:           IMC: 
Tests
   Items
Scores
0
0,5
1
2
Aggravation maneuver 
1
Supine position: aggravation=1 / no aggravation= 0
Aggravation maneuver 
2
Modified state of consciousness (overall relaxation) 
aggravation=1 / no aggravation= 0
Aggravation maneuver 
3
Cephalic flexion: aggravation at the start of flexion (≤ 6°)=2 / in the 
middle of flexion (7—>10°)=1 / at the end of flexion (≥11°)=0
Facilitation maneuver 
4
Cephalic extension: facilitation from the start of extension (≤ 6°)=2 / 
in the middle of extension (7—>10°)=1 / at the end of extension 
(≥11°)=0
Facilitation maneuver 
5
Measurement of range: amplitude between cephalic flexion and 
extension: reduced (≤12°)=2 / medium (13->20°)=1 / large 
(≥21°)=0
Facilitation maneuver 
6
Mandibular advancement: Physiological=2 / Tooth butt =1 / Anterior 
crossing=0.5 / no facilitation= 0
Therapist observation
7
Therapist palpation of the contraction of the buccal floor on 
inspiration at rest yes=2 / no=0
Therapist observation
8
Sound perception of ventilation by the therapist: yes=1 / no=0
Intermediate Final Score (IFS): low risk of OSA ≤ 7.5 / risk of OSA ≥ 8                                                                                                        … / 13   
Aggravated situation
9
Low lingual posture in supine position : yes=2  / no=0
Subjective perception of nasal permeability
10
Do you regularly have difﬁculty breathing through your nose? yes= 
1 / no= 0
Subjective perception of snoring
11
Do you snore at night? yes=1 / no=0       
Subjective perception of daytime ventilation 
patterns
12
During the day, you breathe mainly: through the mouth=1 / mixed 
nose-mouth=0,5 / through the nose =0   
subjective perception of nocturnal breathing 
patterns
13
At night, you breathe mainly: through the mouth=2 / mixed nose-
mouth=1 / through the nose =0
Therapist observation
14
Dento-skeletal class: class I or III = 0 / class II = 1
Therapist observation: Tonsils: grades 0-1-2 
=0 / grades 3-4 =1
15
Quote :
Therapist observation: Mallampati: grade 
1-2 =0 / grade 3-4 =1
16
Quote :
Epworth Sleepiness Scale
17
score:  ≤ 8 =0 /  9–>14 =1 / ≥15 = 2
FFF questionnaire
18
score ≤ 10 =0 / ≥11 =1
Final Total Score (FTS): low risk of OSAS ≤10 / high risk of OSAS ≥11                                                                                                       … / 26   
Comments :
www.osteovox.be
0
1
2
3
4
1
2
3
4

Study process adapted from the CONSORT 2010 ﬂowchart.
STUDY GROUP: The ﬁnal sample included 41 patients diagnosed with OSAH (mild= 9, 
moderate=18; severe= 14). 
The study sample included 13 women and 28 men, with a mean age of 49.30 years, and a 
mean body mass index (BMI) of 30.70 kg/m2. 
CONTROL GROUP: The ﬁnal sample included 60 patients without OSA based on subjective scales used in sleep 
medicine in Liège (Epworth, Berlin, Pichot, FFF).
The study sample comprised 20 men and 40 women, with a mean age of 41.76 years and a mean body mass 
index (BMI) of 22.78 kg/m2. 
Predictability of OSA With a Subjective Screening Scale (OSASSS1)
Excluded from the analysis after unblinding and inclusion of scales 
(n= 30)  
sometimes with several exclusion criteria for the same patients:  
- Epworth (n= 21) 
- Berlin (n= 11) 
- Pichot (n= 1) 
- FFF (n= 6)
Assessed for eligibility (n= 95)
Control group WITHOUT PSG
Analysed (n= 60)
- Physiological (n= 60)
Assessed for eligibility (n= 57)
Experimental group WITH PSG
Excluded from analysis (n=1)
- no PSG data
Assigned to exam (n= 55)
Allocated intervention received (n = 55)
Analysed (n = 52)
- OSA-free (n =11)
- Mild syndrome (n = 9)
- Moderate syndrome (n = 18)
- Severe syndrome (n = 14)
Excluded (n= 5) 
- did not present for clinical examination (n= 4) 
- unable to carry out the examination (n=1)
Excluded (n= 2)
- systemic disease (n=1)
- post-surgery (n=1)
Excluded from examination (n= 2)
- Impossible because of dyskinesis (n =1)
- Impossible because of incomprehension (n = 1)
Assigned to exam (n= 90)
Allocated intervention received (n= 90)
Clinical examination 
Assignment
Analysis
Excluded from analysis (n=11)
- Recruitment bias
« sleep disorders but OSA-free»
Analysed (n = 41)
- Mild syndrome (n = 9)
- Moderate syndrome (n = 18)
- Severe syndrome (n = 14)
Enrollment
preliminary outcome: sensitivity of all 
participants to variations in airﬂow 
according to clinical examination items
primary outcome: predictability of OSA 
according to the score obtained on the 
subjective perception scale
Analysed (n= 60)
- Physiological (n= 60)

Andre Renard Ethics Commi2ee  
 
ID: OSASSS1 - NCT: 06092710 
Predictability of OSA with a SubjecIve Screening Scale 
Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of the Air Flow 
Through Airways, a Randomized Controlled Study 
 
 
 
 
 
 
 
 
Herstal, February 3, 2023 
 
 
 
 
 
Favorable Opinion 
Composition of the Ethics Committee: 
•
- Dr. Anthony Nguyen - Vascular Surgeon 
•
- Dr. Ayse Acar - External General Practitioner 
•
- Dr. Chantal Bully - Palliative Care 
•
- Dr. Dominique Courard - Anesthesiologist 
•
- Dr. Natacha Noël - Geriatrician 
•
- Maı̂tre Jean-Luc Wenric - Lawyer at the Liège Bar 
•
- Ms. Caroline Doppagne - Hospital Mediator 
•
- Ms. Céline Nihoul - Psychologist 
•
- Ms. Dominique Klein - Social Worker 
•
- Ms. Emeline Baptiste - Hospital Pharmacist 
•
- Ms. Jennifer Derison - Nurse in the Intensive Care Unit 
Subject: 
"Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of Air_low 
Through the Upper Airways" 
Dear Dr. Lacroix, 
 
After reviewing the informed consent and receiving the responses to the questions raised 
during the meeting on 12/01/2023, I inform you that the local Ethics Committee of the 
Andre Renard Clinic has issued a favorable opinion regarding the study: 
"Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of Air_low 
Through the Upper Airways." 
The committee considers that the study mentioned above complies with medical ethics 
rules. The study may be carried out. 
Please accept, Dr. Lacroix, the expression of my best regards. 
Dr. Anthony Nguyen, MD, PhD 
Chairman of the Ethics Committee 
Andre Renard Clinic 
anthony.nguyen@cliniqueandrerenard.be

Certiﬁcate of consent to participate in a study protocol at the Sleep Medicine 
Center (CMS): 
“RHINO-OROPHARYNGEAL UPPER AIRWAY PERMEABILITY – SUBJECTIVE 
NEUROSENSORY ASSESSMENT”: 
Investigators: Alain PIRON and Cédric GARCION, osteopaths 
Promoters of the study: Alain LACROIX and Bassam CHAKAR, Ivan SELAK, neurologists from 
the CMS 
I, the undersigned, Miss./Mrs./Mr………………………………………………………………………………………………. 
date of birth ....../..../.... ....    
freely and voluntarily accept to participate in the protocol referenced above, coordinated by 
Alain PIRON and Cédric GARCION supervised by Drs Alain LACROIX, Bassam CHAKAR and Ivan 
SELAK. 
Being heard that : :  
•
The investigators who informed me and clearly answered all my questions, told me that my 
participation is free and that I can withdraw from the protocol at any time. 
•
I was previously given an information note on this protocol, specifying its purpose, its 
methodology, its expected benefits and its foreseeable risks. 
•
I will be able to have communication from the investigators, during or at the end of the 
protocol, of the information they hold concerning my health. 
•
I am perfectly aware that I can withdraw my consent to my participation in this protocol at 
any time, whatever my reasons and without bearing any responsibility. In this case, I 
undertake to inform the investigators. 
•
I may request additional information from the investigators at any time. 
•
If I wish, at the end, I will be informed by the investigators of the overall results of this 
study. 
•
My consent in no way relieves investigators and supervisors of all their responsibilities and I 
retain all my rights guaranteed by law. 
This document must be produced in 2 original copies: the first must be kept by the 
investigator and the second is given to the person giving consent.  
Date :        
Patient Signature :            
               
Signature of the investigators, who attest to having fully explained to the person signing the 
purpose, the modalities as well as the potential risks of the study. 
Date :                                                                          Name and Signature :