Predictability of OSA With a Subjective Screening Scale (OSASSS1)

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Obstructive Sleep Apnea, OSA

Intervention / Treatment
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* Diagnostic Test: neuro-sensorial subjective evaluation of the airways collapsibility


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group with PSG and sleep survey<br>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<br>* verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility<br>* Other names: subjective perception scale of airways collapsibility;|
| control group with sleep survey<br>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<br>* verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility<br>* Other names: subjective perception scale of airways collapsibility;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy correlation of a subjective perception of the airways collapsibility protocol between OSA subjects and control subjects to validate a OSA screening tool | Evaluation of the subjects perception of the air flow using different positions or maneuvers: their answers are noted as positive, negative, neutral or no response for the air flow perception of ease. their answers are noted as up, down for the position of the tongue into the mouth. their answers are noted as nasal, buccal or mixed about their ventilatory habits. their answers are noted of their supposed frequency of dorsal decubitus, lateral decubitus, ventral decubitus. the investigators note the Friedman and Mallampati stage of the tonsils and velum, then the Angle class of dentition. All the items will be allotted (+1), (0), or (-1) score to define a global score which will be analyzed by linear correlation coefficient (Pearson's) in relation to the status, with or without OSA, of each subjects. | during the clinical protocol, about 15 to 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive value on the severity of OSA of the subjective upper airway collapsibility perception scale | Does the precision of the subjective perception scale make it possible to obtain a rating of the factors aggravating or facilitating the passage of air in correlation with the different stages of severity of OSA? the sensitivity and specificity of each element and their overall relevance in relation to the severity stage of OSA. | during the examination protocol, about 15 to 20 minutes | 
| therapeutic material indication tool | Are therapeutic proposals and equipment adapted according to the screening results of each item during the neuro-sensory evaluation protocol? suggestion of therapeutic proposal by yes or no: if head position facilitating collapsibility of the upper airways, indication for a medical pillow, if positive mandibular advancement, indications for an mandibular advancement device, if positive nostril spacing, indication for a nasal dilatator, if position on the back aggravates the collapsibility of the upper airways, indication of an anti-supine belt | during the clinical protocol, about 15 to 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, OSA, obstructive sleep apnea syndrome, sleep disorder, upper airways resistance syndrome UARS, subjective scale of air flow