Cheeks Appearance as a Novel Predictor of Obstructive Sleep Apnea The CASA Score Study

Study Overview
=================
Brief Summary
-----------------
Cheeks appearance is a screening tool developed based on cheeks observation to identify volume, flaccidity or both to predict people with probable obstructive sleep apnea.

Detailed Description
-----------------
Cheeks Appearance for Sleep Apnea (CASA score) is a screening tool developed to observe adults people cheeks appearance to identify volume, being 0 for no volume, 1 for mild volume, 2 for moderate volume and 3 for severe volume; or flaccidity, being 0 for no flaccidity, 1 for mild flaccidity, 2 for moderate flaccidity and 3 for severe flaccidity. In the end of CASA score screening we sum up the score of volume with the score and the flaccidity score to reach the CASA score, the final result that can range from 0 to 6 points. This study was applied in three moments, being the first one only the application of CASA score and a facial imaging to facilitate the replicability. The data collection and enrollment of 248 participants were made in a sleep private clinic in participants undergoing polysomnography. All this part of data collection was applied for a 3 months period. This first part was the validation of CASA score protocol with internal validity. The second part was carried out 1 year after in which all participants enrolled were evaluated by CASA score and facial imaging, as the first part, in a sleep private clinic while doing polysomnography. Additionally, procedures such as ultrasonography images of specific orofacial muscles, followed by tongue and cheeks pressure evaluation were carried out just after the CASA score and facial imaging based on photography registers. In this second part, others 71 participants were recruited. The third and last part was a case-control study in which 20 of the 71 anterior part of the data collection were invited to take part in the last part of the study, that was the fiberoptic endoscopic evaluation of swallowing, so 10 non obstructive sleep apnea participants and 10 obstructive sleep apnea participants were chosen and invited, 19 accepted and carried out the last part. This last part was underwent in an outpatient clinic of an otorhinolaryngologist or ear, nose and throat physician (ENT) with a Speech and Language Therapist (SLT). Description of the methods: Ultrasonography was made with a portable device which was positioned in the face of the participant and slide for the direction needed to capture the image of the muscle targeted like masseter, buccinator and tongue. Those were the three muscles evaluated by the ultrasonography exam. Tongue and cheeks pressure evaluation was made with IOPI medical equipment which had a small bulb coupled in the device and its bulb was positioned inside the mouth of the participant in the tongue and the participant was instructed to press as hard as he could against the hard palate. In the cheeks was positioned in the oral vestibule between the cheek and the teeth, and the pressure was applied by the cheeks. Fiberoptic endoscopic evaluation of swallowing (FEES): a micro camera of a endoscopy was inserted in the participant nose to look the nasopharynx and oropharynx. The fiberoptic was kept in the nasopharynx to see the participant eating, first a liquid consistency (5 and 10 ML), pureed consistency (5 and 10 ML) and solid food (half cracker and 1 whole cracker). The whole exam lasted 15 to 20 minutes, maximum.

Official Title
-----------------
Cheeks Appearance as a Novel Predictor of Obstructive Sleep Apnea The CASA Score Study

Conditions
-----------------
Face, Obstructive Sleep Apnea, Breathing, Sleep-Disordered, Muscle Weakness, Muscle Disorder, Swallowing Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: CASA score protocol to Non-obstructive sleep apnea Group
* Diagnostic Test: CASA score protocol to Mild obstructive sleep apnea Group
* Diagnostic Test: CASA score protocol to Moderate obstructive sleep apnea Group
* Diagnostic Test: CASA score protocol to Severe obstructive sleep apnea Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sleep complaints 18 years old or older Undergoing polysomnography in the private sleep clinic Exclusion Criteria: Previous OSA diagnose Severe comorbidities such as neurologic diseases or others condition that could cause facial edema or facial deformities Facial hair that could difficult the facial landmarks visualization Previous facial surgical procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-OSA Groups<br>Participants with apnea-hypopnea index < 5 events per hour of sleep. | Diagnostic Test: CASA score protocol to Non-obstructive sleep apnea Group<br>* CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.<br>* Other names: Swallowing evaluation by Endoscopy;|
| Mild OSA Group<br>Participants with apnea-hypopnea index > 5 < 15 events per hour of sleep. | Diagnostic Test: CASA score protocol to Mild obstructive sleep apnea Group<br>* CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.<br>* Other names: Swallowing evaluation by Endoscopy;|
| Moderate OSA group<br>Participants with apnea-hypopnea index > 15 < 30 events per hour of sleep. | Diagnostic Test: CASA score protocol to Moderate obstructive sleep apnea Group<br>* CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.<br>* Other names: Swallowing evaluation by Endoscopy;|
| Severe OSA Group<br>Participants with apnea-hypopnea index > 30 events per hour of sleep. | Diagnostic Test: CASA score protocol to Severe obstructive sleep apnea Group<br>* CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.<br>* Other names: Swallowing evaluation by Endoscopy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cheeks appearance | Identify cheeks volume and cheeks flaccidity, choose the correspondent number of volume and flaccidity 0, 1, 2 or 3, sum up both and reach the final score that is CAS score. | Immediately after the evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness evaluation of specific orofacial muscles | Identify the thickness of the masseter, the buccinator and the tongue of each participant and compare with cheeks appearance outcome | Immediately after the evaluation | 
| Tongue and Cheeks pressure | Identify the maximum pressure of the tongue and the maximum pressure of the cheek (both sides) and compare with cheeks appearance and thickness evaluation outcomes. | Immediately after the evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasonography, Obstructive sleep apnea, Polysomnography, Orofacial myofunctional disorders, Speech and Language and Hearing Science, Muscle Contraction, Muscle Strength, Sleep medicine