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

NCT04980586 | Completed

• 1 other identifier: 2018-0314
• Study Type: observational
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Obstructive sleep apnea; Polysomnography; Orofacial myofunctional disorders; Speech and Language and Hearing Science; Ultrasonography; Muscle Contraction; Muscle Strength; Sleep medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Thickness evaluation of specific orofacial muscles

  Immediately after the evaluation

• Tongue and Cheeks pressure

  Immediately after the evaluation

Study Arms (4)

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

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

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

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

Interventions

CASA score protocol to Non-obstructive sleep apnea Group DIAGNOSTIC_TEST

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.

Also known as: 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

Non-OSA Groups

CASA score protocol to Mild obstructive sleep apnea Group DIAGNOSTIC_TEST

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.

Also known as: 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

CASA score protocol to Moderate obstructive sleep apnea Group DIAGNOSTIC_TEST

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.

Also known as: 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

CASA score protocol to Severe obstructive sleep apnea Group DIAGNOSTIC_TEST

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.

Also known as: 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Sleep complaints
• years old or older
• Undergoing polysomnography in the private sleep clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (12)

• Agha B, Johal A. Facial phenotype in obstructive sleep apnea-hypopnea syndrome: a systematic review and meta-analysis. J Sleep Res. 2017 Apr;26(2):122-131. doi: 10.1111/jsr.12485. Epub 2016 Dec 26.

  PMID: 28019049 BACKGROUND

• Harrington JJ, Avidan AY. Treatment of sleep disorders in elderly patients. Curr Treat Options Neurol. 2005 Sep;7(5):339-52. doi: 10.1007/s11940-005-0027-x.

  PMID: 16079039 BACKGROUND

• Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.

  PMID: 19234106 BACKGROUND

• Lee RW, Chan AS, Grunstein RR, Cistulli PA. Craniofacial phenotyping in obstructive sleep apnea--a novel quantitative photographic approach. Sleep. 2009 Jan;32(1):37-45.

  PMID: 19189777 BACKGROUND

• Perri RA, Kairaitis K, Cistulli P, Wheatley JR, Amis TC. Surface cephalometric and anthropometric variables in OSA patients: statistical models for the OSA phenotype. Sleep Breath. 2014 Mar;18(1):39-52. doi: 10.1007/s11325-013-0845-0. Epub 2013 Apr 13.

  PMID: 23584845 BACKGROUND

• Lee RW, Petocz P, Prvan T, Chan AS, Grunstein RR, Cistulli PA. Prediction of obstructive sleep apnea with craniofacial photographic analysis. Sleep. 2009 Jan;32(1):46-52.

  PMID: 19189778 BACKGROUND

• Kim AM, Keenan BT, Jackson N, Chan EL, Staley B, Poptani H, Torigian DA, Pack AI, Schwab RJ. Tongue fat and its relationship to obstructive sleep apnea. Sleep. 2014 Oct 1;37(10):1639-48. doi: 10.5665/sleep.4072.

  PMID: 25197815 BACKGROUND

• Yoshikawa M, Yoshida M, Tsuga K, Akagawa Y, Groher ME. Comparison of three types of tongue pressure measurement devices. Dysphagia. 2011 Sep;26(3):232-7. doi: 10.1007/s00455-010-9291-3. Epub 2010 Jul 11.

  PMID: 20623302 BACKGROUND

• Valbuza JS, de Oliveira MM, Zancanella E, Conti CF, Prado LB, Carvalho LB, do Prado GF. Swallowing dysfunction related to obstructive sleep apnea: a nasal fibroscopy pilot study. Sleep Breath. 2011 May;15(2):209-13. doi: 10.1007/s11325-010-0474-9. Epub 2011 Jan 13.

  PMID: 21229321 BACKGROUND

• Prikladnicki A, Martinez D, Brunetto MG, Fiori CZ, Lenz MDCS, Gomes E. Diagnostic performance of cheeks appearance in sleep apnea. Cranio. 2018 Jul;36(4):214-221. doi: 10.1080/08869634.2017.1376426. Epub 2017 Sep 21.

  PMID: 28933667 BACKGROUND

• Smith-Ryan AE, Fultz SN, Melvin MN, Wingfield HL, Woessner MN. Reproducibility and validity of A-mode ultrasound for body composition measurement and classification in overweight and obese men and women. PLoS One. 2014 Mar 11;9(3):e91750. doi: 10.1371/journal.pone.0091750. eCollection 2014.

  PMID: 24618841 BACKGROUND

• Prikladnicki A, Gomes E, Cortes Reis Sousa LC, Goncalves SC, Martinez D. Cheeks appearance as a novel predictor of obstructive sleep apnea: the CASA score study. J Clin Sleep Med. 2024 Jun 1;20(6):879-885. doi: 10.5664/jcsm.11022.

  PMID: 38217481 DERIVED

Related Links

• Our first study in diagnostic accuracy in obstructive sleep apnea and the basis to this study.

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Muscle Weakness; Muscular Diseases; Facies; Deglutition Disorders; Speech; Language

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuromuscular Diseases; Disease Attributes; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dr. Denis Martinez

  Hospital de Clinicas de Porto Alegre (HCPA)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 28, 2021
• Study Start: January 10, 2019
• Primary Completion: March 26, 2019
• Study Completion: April 26, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

BR (1)