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| Name | Class |
|---|---|
| PIRON Alain, Osteopath - physiotherapist | UNKNOWN |
| LACROIX Alain, neurologist, MD, PhD | UNKNOWN |
| CHAKAR Bassam, neurologist, MD, PhD | UNKNOWN |
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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
The subjects in the study are 18 to 77 years old and present the following conditions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| 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):
| during the examination and the OSASSS protocol (15 to 20 min) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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
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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
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| Name | Affiliation | Role |
|---|---|---|
| Alain LACROIX, Neurologist, PhD | Center of Sleep Medecine - Clinique André Renard | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de médecine du sommeil- Clinique André Renard | Herstal | Liège | 4040 | Belgium |
all data will be shared after anonymization of the subjects
November 2023 to December 2024
Any approved researcher or reviewer who needs the data to compare, experiment or monitor the study for an official agency or international publication will be able to contact us and obtain the study data.
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Recruitment took place by invitation to the sleep laboratory of the Clinique Andre Renard, from 01/01/2023 to 31/12/2023 for the study and control groups.
study group determined by 3 neurologists after analysis of their polysomnography to form subgroups with mild, moderate and severe OSA. control group determined by questionnaires sent to subjects. The questionnaires had to have responses below the scores for suspected sleepiness or fatigue in order to be included in the control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility |
| FG001 | 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: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
52 participants in the study group with PSG and sleep survey: 11 with a negative diagnosis for sleep apnea 9 with a positive diagnosis of mild OSA 18 with a positive diagnosis of moderate OSA 14 with a positive diagnosis of severe OSA 60 participants in the control group with sleep survey: all negative for suspicion of sleep apnea with 4 questionnaires these are not results or a conclusion drawn from the results, but a factual description of the composition of the groups as requested.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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):
| Discrete grouping variables : healthy patients (= non CHR control patients and normal CHR patients) - STATUS 3: 2 categories: non-OSA (control patients and non-OSA CHR patients) and OSA patients (= CHR patients affected to varying degrees) | Posted | Median | 99% Confidence Interval | score on a scale | during the clinical protocol, about 15 to 20 minutes |
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CEDRIC GARCION | CAndreRenard | +33661817274 | cedric.garcion.osteo@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 11, 2025 | Jun 2, 2025 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| during the examination protocol, about 15 to 20 minutes |
| BG001 | 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: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index Body Mass Index (BMI) units: kg/m2 Mean (Standard Deviation) | Mean | Standard Deviation | kg/m2 |
|
| Epworth Sleepiness Scale | The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0 (no chance of dozing) to 3 (high chance of dozing). When you finish the test, add up the values of your responses. Your total score is based on a scale of 0 to 24.
| Mean | Standard Deviation | units on a scale |
|
|
|
|
|
| Primary | 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):
| free-OSA subjects from the CHR (n=11) were excluded from the study group because they had sleep disorders other than OSA | Posted | Mean | 99% Confidence Interval | score on a scale | during the examination and the OSASSS protocol (15 to 20 min) |
|
|
|
|
| Secondary | 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. | 4 categories:
Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): ANOVAs were performed. For discrete variables with more than 2 levels of value , a post-hoc 2-to-2 comparison analysis was performed (Tukey). | Posted | Mean | 95% Confidence Interval | score on a scale | during the examination protocol, about 15 to 20 minutes |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | 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: verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility | 0 | 60 | 0 | 60 | 0 | 60 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| Parametric tests on the prediction of patients' pathological status with SFT score (Final Total score): For these analyses, as SFT score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable differed from one another. | ANOVA | 0000000048 | Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level) | Superiority |
| Determination of cut-off values for SFI: The Cutoff_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-off value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically. | Fisher Exact | 0.00000077 | Odds Ratio (OR) | 8.73 | 2-Sided | Superiority |
| Determination of cut-off values for SFT: The Cutoff_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-off value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically. | Fisher Exact | 0.00000069 | Odds Ratio (OR) | 9.37 | 2-Sided | Superiority |
| total final score (TFS) |
|
Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable differed from one another. |
| TUKEY TEST |
| 0.0023308 |
| Superiority |
| Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable differed from one another. | TUKEY TEST | 0.0023308 | Superiority |
| Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable differed from one another. | TUKEY TEST | 0.9915779 | Superiority |
| Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable differed from one another. | TUKEY TEST | 0.9999943 | Superiority |
| Parametric tests on the prediction of patients' pathological status (SFI and SFT scores): For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable differed from one another. | TUKEY TEST | 0.9905111 | Superiority |