Obstructive Sleep Apnea, OSA
Conditions
Keywords
obstructive sleep apnea, OSA, obstructive sleep apnea syndrome, sleep disorder, upper airways resistance syndrome UARS, subjective scale of air flow
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
Interventions
DIAGNOSTIC_TESTneuro-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
Sponsors
PIRON Alain, Osteopath - physiotherapist
LACROIX Alain, neurologist, MD, PhD
CHAKAR Bassam, neurologist, MD, PhD
Center for Sleep Medicine - Clinique André Renard
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | 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. |
Countries
Belgium
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 52 |
| 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 | 60 |
| Total | 112 |
Baseline characteristics
| Characteristic | Study Group With PSG and Sleep Survey | Control Group With Sleep Survey | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 57 Participants | 104 Participants |
| Age, Continuous | 49.9 years STANDARD_DEVIATION 11.8 | 41.8 years STANDARD_DEVIATION 12.8 | 44.6 years STANDARD_DEVIATION 13 |
| Body Mass Index Body Mass Index (BMI) units: kg/m2 Mean (Standard Deviation) | 29.3 kg/m2 STANDARD_DEVIATION 5.8 | 22.8 kg/m2 STANDARD_DEVIATION 3.3 | 25.8 kg/m2 STANDARD_DEVIATION 5.7 |
| Epworth Sleepiness Scale | 10.8 units on a scale STANDARD_DEVIATION 5.35 | 5.6 units on a scale STANDARD_DEVIATION 2.2 | 8 units on a scale STANDARD_DEVIATION 4.76 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Belgium | 52 participants | 60 participants | 112 participants |
| Sex: Female, Male Female | 25 Participants | 40 Participants | 65 Participants |
| Sex: Female, Male Male | 27 Participants | 20 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 60 |
| other Total, other adverse events | 0 / 52 | 0 / 60 |
| serious Total, serious adverse events | 0 / 52 | 0 / 60 |
Outcome results
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): * 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
Time frame: during the examination and the OSASSS protocol (15 to 20 min)
Population: free-OSA subjects from the CHR (n=11) were excluded from the study group because they had sleep disorders other than OSA
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Group With PSG and Sleep Survey | Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool | 8.63 score on a scale |
| Control Group With Sleep Survey | Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool | 5.92 score on a scale |
Comparison: Parametric tests on the prediction of patients' pathological status with SFI (Intermediate Final Score) For these analyses, as the SFI 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.p-value: 0.00000106ANOVA
Comparison: 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.p-value: 48ANOVA
Comparison: 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.p-value: 7.7e-7Fisher Exact
Comparison: 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.p-value: 6.9e-7Fisher Exact
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): * 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.
Time frame: during the clinical protocol, about 15 to 20 minutes
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Group With PSG and Sleep Survey | 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 | 5 score on a scale |
| Control Group With Sleep Survey | 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 | 4 score on a scale |
Comparison: Non-parametric tests on patient sensitivity, given the non-normal distribution, (based on the median of the data) were applied to analyse the differences between the groups (ST1+ ST2 according to the STATUS3 and STATUS4 classification criteria). To analyse any differences in sensitivity between patient groups, Kruskal-Wallis tests were applied. In this type of analysis, having a p-value greater than 1% and ideally greater than 5% would indicate the absence of differences between groups.p-value: 0.05572Kruskal-Wallis
Comparison: to see if the median of a particular group is different from 0 (= no sensitivity: not feeling the differences in airflow induced by the different tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the differences in airflow depending on their position.p-value: <8e-7Wilcoxon (Mann-Whitney)
Comparison: to see if the median of a particular group is different from 0 (= no sensitivity: not feeling the differences in airflow induced by the different tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the differences in airflow depending on their position.p-value: <1e-7Wilcoxon (Mann-Whitney)
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.
Time frame: during the examination protocol, about 15 to 20 minutes
Population: 4 categories:~* control patients,~* mild symptom patients (CHR SL),~* moderate symptom patients (CHR SM)~* severe symptom patients (CHR SS) free-OSA patients from the CHR study group (n=11) were excluded because they had sleep pathologies other than OSA~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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Study Group With PSG and Sleep Survey | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | intermediate final score (IFS) | 5.92 score on a scale |
| Study Group With PSG and Sleep Survey | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | total final score (TFS) | 8.26 score on a scale |
| Control Group With Sleep Survey | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | total final score (TFS) | 12.89 score on a scale |
| Control Group With Sleep Survey | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | intermediate final score (IFS) | 8.78 score on a scale |
| Moderate Symptom Patients (= CHR SM) | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | intermediate final score (IFS) | 8.47 score on a scale |
| Moderate Symptom Patients (= CHR SM) | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | total final score (TFS) | 12.33 score on a scale |
| Severe Symptom Patients (=CHR SS) | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | intermediate final score (IFS) | 8.75 score on a scale |
| Severe Symptom Patients (=CHR SS) | Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale | total final score (TFS) | 13.61 score on a scale |
Comparison: 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.p-value: 0.0142266TUKEY TEST
Comparison: 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.p-value: 0.0023308TUKEY TEST
Comparison: 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.p-value: 0.0023308TUKEY TEST
Comparison: 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.p-value: 0.9915779TUKEY TEST
Comparison: 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.p-value: 0.9999943TUKEY TEST
Comparison: 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.p-value: 0.9905111TUKEY TEST