Predictability of OSA With a Subjective Screening Scale (OSASSS1)

Obstructive Sleep Apnea Clinical Trial

— OSASSS1  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06092710
• Other study ID #: OSASSS1
• Status: Enrolling by invitation
• Start date: January 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Center for Sleep Medicine - Clinique André Renard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: September 30, 2024
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• OSA
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Belgium	Centre de médecine du sommeil- Clinique André Renard	Herstal	Liège

Sponsors (5)

Lead Sponsor	Collaborator
Center for Sleep Medicine - Clinique André Renard	CHAKAR Bassam, neurologist, MD, PhD, LACROIX Alain, neurologist, MD, PhD, PIRON Alain, Osteopath - physiotherapist, SELAK Ivan, neurologist, MD, PhD

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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