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

July 22, 2021 updated by: Hospital de Clinicas de Porto Alegre
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

319

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035903
        • Hospital de Clinicas de Porto Alegre (HCPA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults over 18 years old with sleep complaints undergoing he polysomnography in the private sleep clinic during the data collection period.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-OSA Groups
Participants with apnea-hypopnea index < 5 events per hour of sleep.
Diagnostic test: CASA score protocol to Non-obstructive sleep apnea Group
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.
Other Names:
  • Photography registers
  • Ultrasonography in Specific Orofacial Muscles by BodyMetrix device
  • Tongue and Cheeks Pressure Evaluation by Iowa Oral Performance Instrument Medical Device
  • Swallowing evaluation by Endoscopy
Mild OSA Group
Participants with apnea-hypopnea index > 5 < 15 events per hour of sleep.
Diagnostic test: CASA score protocol to Mild obstructive sleep apnea Group
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.
Other Names:
  • Photography registers
  • Ultrasonography in Specific Orofacial Muscles by BodyMetrix device
  • Tongue and Cheeks Pressure Evaluation by Iowa Oral Performance Instrument Medical Device
  • Swallowing evaluation by Endoscopy
Moderate OSA group
Participants with apnea-hypopnea index > 15 < 30 events per hour of sleep.
Diagnostic test: CASA score protocol to Moderate obstructive sleep apnea Group
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.
Other Names:
  • Photography registers
  • Ultrasonography in Specific Orofacial Muscles by BodyMetrix device
  • Tongue and Cheeks Pressure Evaluation by Iowa Oral Performance Instrument Medical Device
  • Swallowing evaluation by Endoscopy
Severe OSA Group
Participants with apnea-hypopnea index > 30 events per hour of sleep.
Diagnostic test: CASA score protocol to Severe obstructive sleep apnea Group
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.
Other Names:
  • Photography registers
  • Ultrasonography in Specific Orofacial Muscles by BodyMetrix device
  • Tongue and Cheeks Pressure Evaluation by Iowa Oral Performance Instrument Medical Device
  • Swallowing evaluation by Endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cheeks appearance
Time Frame: Immediately after the evaluation
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
Time Frame: Immediately after the evaluation
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
Time Frame: Immediately after the evaluation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Study Chair: Dr. Denis Martinez, Hospital de Clinicas de Porto Alegre (HCPA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

March 26, 2019

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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