Predictability of OSA With a Subjective Screening Scale (OSASSS1) (OSASSS1)

Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of the Air Flow Through Airways, a Randomized Controlled Study

the study aims to evaluate the accuracy correlation between subjective perception of the air flow through airways from patients and survey and/or polysomnography they spent, using a brief clinical protocol they answered with a manual therapist

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; OSA
• Intervention / Treatment: Diagnostic test: neuro-sensorial subjective evaluation of the airways collapsibility

Detailed Description

The subjects in the study are 18 to 77 years old and present the following conditions:

• polysomnography and sleep survey realized at the Center for Sleep Medicine André RENARD, without any informations of the results for the experience group
• sleep survey with no sleep trouble found for the control group

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Belgium
  • Liège
    • Herstal, Liège, Belgium, 4040
      • Centre de médecine du sommeil- Clinique André Renard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

subjects with OSA objectified after polysomnography, sleepiness Epworth scale, fatigue Pichot scale, and subjects without OSA specified by negativation at sleepiness Epworth scale, fatigue Pichot scale, Berlin questionnaire

Description

Inclusion Criteria:

• Female or male subjects aged 18 to 77 years old
• subjects who have performed a PSG at the sleep medicine center André Renard for the study group
• subjects with no sleep disorder on sleep survey for the control group
• Subjects who agree to comply with the requirements of the study.
• Subjects who are of age (and know how to read and write) who have given their informed, explicit consent in advance to any procedure related to the trial, the study or the investigation conducted on human beings, with the objective of developing knowledge specific to the exercise of health care professions, as set out in Royal Decree No. 78 of 10 November 1967 on the practice of the health care professions (Act of 27 December 2005)

Exclusion Criteria:

• subjects with acute infections
• subjects with trauma within the last 72 hours
• subjects who already benefit from OSA treatment
• subjects with known perceptual disorders, for example post-stroke
• subjects with current or recent chemotherapy and radiotherapy treatment
• Pregnant women
• Criteria related to prior or concurrent treatments:

Treatment with antipsychotics, anxiolytics, soporifics or muscle relaxants started within the two months preceding the study.

Treatment with intraoral implants during the study or in the two months preceding the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: 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; Other Names: subjective perception scale of the air flow through airways; subjective perception of the air flow protocol; protocol of subjective perception of airways collapsibility; subjective perception scale of 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	Diagnostic test: 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; Other Names: subjective perception scale of the air flow through airways; subjective perception of the air flow protocol; protocol of subjective perception of airways collapsibility; subjective perception scale of airways collapsibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	during the clinical protocol, about 15 to 20 minutes
Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool	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	during the examination and the OSASSS protocol (15 to 20 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale	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.	during the examination protocol, about 15 to 20 minutes

Collaborators and Investigators

• Sponsor: Center for Sleep Medicine - Clinique André Renard
• Collaborators: PIRON Alain, Osteopath - physiotherapist; LACROIX Alain, neurologist, MD, PhD; CHAKAR Bassam, neurologist, MD, PhD
• Investigators: Study Chair: Alain LACROIX, Neurologist, PhD, Center of Sleep Medecine - Clinique André Renard

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: obstructive sleep apnea syndrome; OSA; obstructive sleep apnea; sleep disorder; upper airways resistance syndrome UARS; subjective scale of air flow
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: OSASSS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all data will be shared after anonymization of the subjects
• IPD Sharing Time Frame: November 2023 to December 2024
• IPD Sharing Access Criteria: Any approved researcher or reviewer who needs the data to compare, experiment or monitor the study for an official agency or international publication will be able to contact us and obtain the study data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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