Obstructive Sleep ApneaOSASSS1NCT06092710
Predictability of OSA With a Subjective Screening Scale (OSASSS1)
An observational study of Obstructive Sleep Apnea and OSA, run by Center for Sleep Medicine - Clinique André Renard at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, OSA
- What is being tested?
- neuro-sensorial subjective evaluation of the airways collapsibility
- How many people
- 112 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2023to 30 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre de médecine du sommeil- Clinique André Renard
Herstal, Liège, 4040
About this study
Official title: Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of the Air Flow Through Airways, a Randomized Controlled Study
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
Read the 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
- Being tested
- neuro-sensorial subjective evaluation of the airways collapsibility
- Keywords
- obstructive sleep apnea, OSA, obstructive sleep apnea syndrome, sleep disorder, upper airways resistance syndrome UARS, subjective scale of air flow
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuro-sensorial subjective evaluation of the airways collapsibilityDiagnostic test
Also called 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
verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: neuro-sensorial subjective evaluation of the 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 Receives: Diagnostic Test: neuro-sensorial subjective evaluation of the airways collapsibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: during the clinical protocol, about 15 to 20 minutes
Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool
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
Measured: during the examination and the OSASSS protocol (15 to 20 min)
Secondary outcomes (1)
Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale
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.
Measured: during the examination protocol, about 15 to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2023
- Primary completion19 Jun 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Sleep Medicine - Clinique André Renard
- Sponsor type
- University, hospital or other
- Collaborators
- PIRON Alain, Osteopath - physiotherapist, LACROIX Alain, neurologist, MD, PhD, CHAKAR Bassam, neurologist, MD, PhD
- Responsible party
- Principal investigator, GARCION Cédric, Center for Sleep Medicine - Clinique André Renard
- Investigators
- Alain LACROIX, Neurologist, PhD, Study chair, Center of Sleep Medecine - Clinique André Renard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092710
- Sponsor's protocol ID
- OSASSS1
- Acronym
- OSASSS1
- Status last verified
- Jun 2025
- First submitted
- 7 Oct 2023
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be shared after anonymization of the subjects
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of OSA Based on the Evaluation of the Subjective Feeling of the Air Flow Through Airways, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06092710
- Acronym / sponsor ID
- OSASSS1 / OSASSS1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Center for Sleep Medicine - Clinique André RenardUniversity, hospital or other
- Collaborators
- PIRON Alain, Osteopath - physiotherapist, LACROIX Alain, neurologist, MD, PhD, CHAKAR Bassam, neurologist, MD, PhD
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Posted 3 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group with PSG and sleep survey | – | Diagnostic Test: neuro-sensorial subjective evaluation of the airways collapsibilitythe 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 |
| control group with sleep survey | – | Diagnostic Test: neuro-sensorial subjective evaluation of the airways collapsibilitythe 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 |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuro-sensorial subjective evaluation of the airways collapsibilityAlso: 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 collapsibilityverbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility | Diagnostic test | control group with sleep survey, study group with PSG and sleep survey |
Primary outcome
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.
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. all data will be shared after anonymization of the subjects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain LACROIX, Neurologist, PhD study chair
Center of Sleep Medecine - Clinique André Renard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and OSA, run by Center for Sleep Medicine - Clinique André Renard at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: during the clinical protocol, about 15 to 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.