Predictability of OSA With a Subjective Screening Scale (OSASSS1)

Sponsor

Center for Sleep Medicine - Clinique André Renard (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06092710

Collaborator

PIRON Alain, Osteopath - physiotherapist (Other), LACROIX Alain, neurologist, MD, PhD (Other), CHAKAR Bassam, neurologist, MD, PhD (Other), SELAK Ivan, neurologist, MD, PhD (Other)

110

Enrollment

Location

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea OSA	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 Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

accuracy correlation of a subjective perception of the airways collapsibility protocol between OSA subjects and control subjects to validate a OSA screening tool [during the clinical protocol, about 15 to 20 minutes]
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.

Secondary Outcome Measures

predictive value on the severity of OSA of the subjective upper airway collapsibility perception scale [during the examination protocol, about 15 to 20 minutes]
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.
therapeutic material indication tool [during the clinical protocol, about 15 to 20 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)