Predictability of OSA With a Subjective Screening Scale (OSASSS1)
- Conditions
- OSAObstructive Sleep Apnea
- Interventions
- Diagnostic Test: neuro-sensorial subjective evaluation of the airways collapsibility
- Registration Number
- NCT06092710
- Lead Sponsor
- Center for Sleep Medicine - Clinique André Renard
- 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
- 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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 110
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description control group with sleep survey neuro-sensorial subjective evaluation of the airways collapsibility 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 study group with PSG and sleep survey neuro-sensorial subjective evaluation of the airways collapsibility 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Centre de médecine du sommeil- Clinique André Renard
🇧🇪Herstal, Liège, Belgium