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Completed

NCT Number: NCT06092710

Predictability of OSA With a Subjective Screening Scale (OSASSS1)

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations OSA Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de médecine du sommeil- Clinique André Renard

Herstal, Liège, 4040, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neuro-sensorial subjective evaluation of the airways collapsibility

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

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

Primary outcomes

  1. 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

    Time frame: during the clinical protocol, about 15 to 20 minutes

    In this study, we set out to create a scale of subjective perception of airflow. Assessment of subjects' perception of airflow using different positions or maneuvers: responses are scored for perceived ease of airflow.

    Items will be assigned "0" if they feel no expected change in airflow due to the maneuver up to "+1" if they feel a variation corresponding to the maneuver. Summed together, they define a score by item category (ST):

    • "constraining" (ST1: min= 0/Max= 4: dorsal decubitus "0/1", modified state of consciousness "0/1", cephalic flexion "0/1", tongue high to low position "0/1")
    • "facilitating" (ST2: min= 0/max=3: mandibular advancement "0/1", cephalic extension "0/1", nasal dilatation "0/1") to then assess whether the sensation of "facilitated or constrained" variation in the passage of air (ST1+ST2: min=0/max=7) is statistically significant for each group of participants compared to the absence of sensation of variation.

  2. Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool

    Time frame: during the examination and the OSASSS protocol (15 to 20 min)

    In this study, we set out to create a scale, so we can only describe what we did.

    score by item category (ST):

    • ST1+ST2 (min=0/max=10) corresponds to the sensitivity of "facilitated or constrained" variation in the passage of air.
    • ST3: (min=0/max=3) corresponds to the practitioner's palpation of a synchronous contraction of the floor of the mouth (ventilatory defense sign) and sound turbulence on inspiration
    • ST4 (min=0/max=2) corresponds to lingual posture in supine position (aggravating if low)
    • ST5 (min=0/max=5) corresponds to patients' subjective perception of easy nasal ventilation, snoring, daytime ventilatory mode and nocturnal ventilatory mode
    • ST6 (min=0/max=3) corresponds to the teeth-skeletal class, tonsil grades and Mallampati stages
    • Epworth (min=0/max=2) corresponds to suspected sleep debt
    • FFF (min=0/max=1) corresponds to suspected fatigue SFI (min=0/max=13) corresponds to ST1+ST2+ST3 SFT (min=0/max=26) corresponds to SFI+ST4+ST5+ST6+Epworth+FFF

Secondary outcomes

  1. Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale

    Time frame: during the examination protocol, about 15 to 20 minutes

    Objective: to determine an intermediate final score (IFS) and total final score (TFS) threshold for classifying the severity of OSA in at-risk subjects. The questionnaire comprises 18 questions relating to upper airway collapsibility. Each item concerns the aggravating or facilitating factors perceived by the patient or therapist during the clinical maneuvers used to obtain the IFS. To obtain the TFS, we add items concerning factors known to be unfavorable to upper airway patency (snoring, mouth ventilation, tonsils, dento-skeletal class, etc.), as well as two questionnaires used in the sleep laboratory at the André Renard Clinic (Epworth sleepiness scale and FFF questionnaire). IFS: min=0/max=13. TFS: min= 0/max=26. The higher the score, the greater the risk of OSA. Clinically, the scale is designed to perform the IFS, giving a score out of 13. Then, if the score is above the first cut-off point, the questionnaire is completed to establish the TFS out of 26.

Sponsors and collaborators

Lead sponsor

Center for Sleep Medicine - Clinique André Renard

Other

Collaborators

  • CHAKAR Bassam, neurologist, MD, PhD
  • LACROIX Alain, neurologist, MD, PhD
  • PIRON Alain, Osteopath - physiotherapist

Registry information

Official study title

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

Acronym: OSASSS1

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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