Predictability of OSA With a Subjective Screening Scale (OSASSS1)

NCT ID: NCT06092710

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-11-30

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

Conditions

Obstructive Sleep Apnea; OSA

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

neuro-sensorial subjective evaluation of the airways collapsibility

Intervention Type: DIAGNOSTIC_TEST

verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and 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

neuro-sensorial subjective evaluation of the airways collapsibility

Intervention Type: DIAGNOSTIC_TEST

verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention 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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PIRON Alain, Osteopath - physiotherapist

UNKNOWN

Sponsor Role: collaborator

LACROIX Alain, neurologist, MD, PhD

UNKNOWN

Sponsor Role: collaborator

CHAKAR Bassam, neurologist, MD, PhD

UNKNOWN

Sponsor Role: collaborator

Center for Sleep Medicine - Clinique André Renard

OTHER

Sponsor Role: lead

Responsible Party

GARCION Cédric

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alain LACROIX, Neurologist, PhD

Role: STUDY_CHAIR

Center of Sleep Medecine - Clinique André Renard

Locations

Centre de médecine du sommeil- Clinique André Renard

Herstal, Liège, Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

OSASSS1

Identifier Type: -

Identifier Source: org_study_id