Trial Outcomes & Findings for Predictability of OSA With a Subjective Screening Scale (OSASSS1) (NCT NCT06092710)

Last Updated: 2025-06-03

Results Overview

In this study, we set out to create a scale of subjective perception of airflow. Assessment of subjects' perception of airflow using different positions or maneuvers: responses are scored for perceived ease of airflow. Items will be assigned "0" if they feel no expected change in airflow due to the maneuver up to "+1" if they feel a variation corresponding to the maneuver. Summed together, they define a score by item category (ST): * "constraining" (ST1: min= 0/Max= 4: dorsal decubitus "0/1", modified state of consciousness "0/1", cephalic flexion "0/1", tongue high to low position "0/1") * "facilitating" (ST2: min= 0/max=3: mandibular advancement "0/1", cephalic extension "0/1", nasal dilatation "0/1") to then assess whether the sensation of "facilitated or constrained" variation in the passage of air (ST1+ST2: min=0/max=7) is statistically significant for each group of participants compared to the absence of sensation of variation.

Recruitment status

COMPLETED

Target enrollment

112 participants

Primary outcome timeframe

during the clinical protocol, about 15 to 20 minutes

Results posted on

2025-06-03

Participant Flow

Recruitment took place by invitation to the sleep laboratory of the Clinique Andre Renard, from 01/01/2023 to 31/12/2023 for the study and control groups. study group determined by 3 neurologists after analysis of their polysomnography to form subgroups with mild, moderate and severe OSA. control group determined by questionnaires sent to subjects. The questionnaires had to have responses below the scores for suspected sleepiness or fatigue in order to be included in the control group.

Participant milestones

Participant milestones
Measure	Study Group With PSG and Sleep Survey the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Control Group With Sleep Survey the control group will be recruited after a sleep survey with no sleep disorder. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility
Overall Study STARTED	52	60
Overall Study COMPLETED	52	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group With PSG and Sleep Survey n=52 Participants the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Control Group With Sleep Survey n=60 Participants the control group will be recruited after a sleep survey with no sleep disorder. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=52 Participants	0 Participants n=60 Participants	0 Participants n=112 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=52 Participants	57 Participants n=60 Participants	104 Participants n=112 Participants
Age, Categorical >=65 years	5 Participants n=52 Participants	3 Participants n=60 Participants	8 Participants n=112 Participants
Age, Continuous	49.9 years STANDARD_DEVIATION 11.8 • n=52 Participants	41.8 years STANDARD_DEVIATION 12.8 • n=60 Participants	44.6 years STANDARD_DEVIATION 13.0 • n=112 Participants
Sex: Female, Male Female	25 Participants n=52 Participants	40 Participants n=60 Participants	65 Participants n=112 Participants
Sex: Female, Male Male	27 Participants n=52 Participants	20 Participants n=60 Participants	47 Participants n=112 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	52 participants n=52 Participants	60 participants n=60 Participants	112 participants n=112 Participants
Body Mass Index Body Mass Index (BMI) units: kg/m2 Mean (Standard Deviation)	29.3 kg/m2 STANDARD_DEVIATION 5.8 • n=52 Participants	22.8 kg/m2 STANDARD_DEVIATION 3.3 • n=60 Participants	25.8 kg/m2 STANDARD_DEVIATION 5.7 • n=112 Participants
Epworth Sleepiness Scale	10.8 units on a scale STANDARD_DEVIATION 5.35 • n=52 Participants	5.6 units on a scale STANDARD_DEVIATION 2.2 • n=60 Participants	8 units on a scale STANDARD_DEVIATION 4.76 • n=112 Participants

PRIMARY outcome

Timeframe: during the clinical protocol, about 15 to 20 minutes

Population: Discrete grouping variables : healthy patients (= non CHR control patients and normal CHR patients) \- STATUS 3: 2 categories: non-OSA (control patients and non-OSA CHR patients) and OSA patients (= CHR patients affected to varying degrees)

Outcome measures

Outcome measures
Measure	Study Group With PSG and Sleep Survey n=52 Participants the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Control Group With Sleep Survey n=60 Participants the control group will be recruited after a sleep survey with no sleep disorder. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Moderate Symptom Patients (= CHR SM) the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility Overall Number of Participants Analyzed: 18	Severe Symptom Patients (=CHR SS) the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility Overall Number of Participants Analyzed: 14
Test of Perception of Variations in the Passage of an Airflow Through the Rhino-oro-pharyngeal Passages According to the Categories of Items Used in the OSASSS Subjective Perception Scale	5 score on a scale Interval 2.0 to 6.0	4 score on a scale Interval 0.0 to 7.0	—	—

PRIMARY outcome

Timeframe: during the examination and the OSASSS protocol (15 to 20 min)

Population: free-OSA subjects from the CHR (n=11) were excluded from the study group because they had sleep disorders other than OSA

In this study, we set out to create a scale, so we can only describe what we did. score by item category (ST): * ST1+ST2 (min=0/max=10) corresponds to the sensitivity of "facilitated or constrained" variation in the passage of air. * ST3: (min=0/max=3) corresponds to the practitioner's palpation of a synchronous contraction of the floor of the mouth (ventilatory defense sign) and sound turbulence on inspiration * ST4 (min=0/max=2) corresponds to lingual posture in supine position (aggravating if low) * ST5 (min=0/max=5) corresponds to patients' subjective perception of easy nasal ventilation, snoring, daytime ventilatory mode and nocturnal ventilatory mode * ST6 (min=0/max=3) corresponds to the teeth-skeletal class, tonsil grades and Mallampati stages * Epworth (min=0/max=2) corresponds to suspected sleep debt * FFF (min=0/max=1) corresponds to suspected fatigue SFI (min=0/max=13) corresponds to ST1+ST2+ST3 SFT (min=0/max=26) corresponds to SFI+ST4+ST5+ST6+Epworth+FFF

Outcome measures

Outcome measures
Measure	Study Group With PSG and Sleep Survey n=41 Participants the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Control Group With Sleep Survey n=60 Participants the control group will be recruited after a sleep survey with no sleep disorder. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Moderate Symptom Patients (= CHR SM) the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility Overall Number of Participants Analyzed: 18	Severe Symptom Patients (=CHR SS) the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility Overall Number of Participants Analyzed: 14
Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool	8.63 score on a scale Interval 7.84 to 9.43	5.92 score on a scale Interval 5.27 to 6.58	—	—

SECONDARY outcome

Timeframe: during the examination protocol, about 15 to 20 minutes

Population: 4 categories: * control patients, * mild symptom patients (CHR SL), * moderate symptom patients (CHR SM) * severe symptom patients (CHR SS) free-OSA patients from the CHR study group (n=11) were excluded because they had sleep pathologies other than OSA Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): ANOVAs were performed. For discrete variables with more than 2 levels of value , a post-hoc 2-to-2 comparison analysis was performed (Tukey).

Objective: to determine an intermediate final score (IFS) and total final score (TFS) threshold for classifying the severity of OSA in at-risk subjects. The questionnaire comprises 18 questions relating to upper airway collapsibility. Each item concerns the aggravating or facilitating factors perceived by the patient or therapist during the clinical maneuvers used to obtain the IFS. To obtain the TFS, we add items concerning factors known to be unfavorable to upper airway patency (snoring, mouth ventilation, tonsils, dento-skeletal class, etc.), as well as two questionnaires used in the sleep laboratory at the André Renard Clinic (Epworth sleepiness scale and FFF questionnaire). IFS: min=0/max=13. TFS: min= 0/max=26. The higher the score, the greater the risk of OSA. Clinically, the scale is designed to perform the IFS, giving a score out of 13. Then, if the score is above the first cut-off point, the questionnaire is completed to establish the TFS out of 26.

Outcome measures

Outcome measures
Measure	Study Group With PSG and Sleep Survey n=60 Participants the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Control Group With Sleep Survey n=9 Participants the control group will be recruited after a sleep survey with no sleep disorder. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility	Moderate Symptom Patients (= CHR SM) n=18 Participants the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility Overall Number of Participants Analyzed: 18	Severe Symptom Patients (=CHR SS) n=14 Participants the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol neuro-sensorial subjective evaluation of the airways collapsibility: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility Overall Number of Participants Analyzed: 14
Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale intermediate final score (IFS)	5.92 score on a scale Interval 5.26 to 6.59	8.78 score on a scale Interval 7.06 to 10.49	8.47 score on a scale Interval 7.26 to 9.69	8.75 score on a scale Interval 7.37 to 10.13
Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale total final score (TFS)	8.26 score on a scale Interval 7.34 to 9.18	12.89 score on a scale Interval 10.52 to 15.26	12.33 score on a scale Interval 10.66 to 14.01	13.61 score on a scale Interval 11.71 to 15.51

Adverse Events

Study Group With PSG and Sleep Survey

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group With Sleep Survey

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CEDRIC GARCION

CAndreRenard

Phone: +33661817274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place