Clinical trial NCT06092710: Predictability of OSA With a Subjective Screening Scale (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
OSA
Keywords: obstructive sleep apnea
OSA
obstructive sleep apnea syndrome
sleep disorder
upper airways resistance syndrome UARS
subjective scale of air flow
Lead sponsor: Center for Sleep Medicine - Clinique André Renard
Sponsor class: OTHER
Collaborators: name: PIRON Alain, Osteopath - physiotherapist
name: LACROIX Alain, neurologist, MD, PhD
name: CHAKAR Bassam, neurologist, MD, PhD
First posted: 2023-10-23
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with OSA objectified after polysomnography, sleepiness Epworth scale, fatigue Pichot scale, and subjects without OSA specified by negativation at sleepiness Epworth scale, fatigue Pichot scale, Berlin questionnaire

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

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

Primary outcomes:
measure: Test of Perception of Variations in the Passage of an Airflow Through the Rhino-oro-pharyngeal Passages According to the Categories of Items Used in the OSASSS Subjective Perception Scale
timeFrame: during the clinical protocol, about 15 to 20 minutes
measure: Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool
timeFrame: during the examination and the OSASSS protocol (15 to 20 min)
Secondary outcomes:
measure: Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale
timeFrame: during the examination protocol, about 15 to 20 minutes
Other outcomes:
Locations:
city: Herstal
country: Belgium
facility: Centre de médecine du sommeil- Clinique André Renard
state: Liège
Study officials:
affiliation: Center of Sleep Medecine - Clinique André Renard
name: Alain LACROIX, Neurologist, PhD
role: STUDY_CHAIR
References: