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At a glance

ClinicalIndex Comparison Record
N/ACompleted· 319 enrolled
Drug / intervention
CASA score protocol to Non-obstructive sleep apnea Group +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04980586
NCT04980586N/ACompleted

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

Hospital de Clinicas de Porto Alegre·observational·Posted Jul 28, 2021·Updated Jul 28, 2021

In Brief

An observational study evaluating CASA score protocol to Non-obstructive sleep apnea Group, CASA score protocol to Mild obstructive sleep apnea Group, and 2 other interventions for Obstructive Sleep Apnea and 5 related conditions. Completed, enrolled 319 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 28, 2021
Enrollment StartJan 10, 2019
Primary CompletionMar 26, 2019
Study CompletionApr 26, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.9 years ago

Interventions

CASA score protocol to Non-obstructive sleep apnea Groupother

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.

CASA score protocol to Mild obstructive sleep apnea Groupother

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.

CASA score protocol to Moderate obstructive sleep apnea Groupother

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.

CASA score protocol to Severe obstructive sleep apnea Groupother

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.