Obstructive Sleep ApneaCASANCT04980586
Cheeks Appearance as a Novel Predictor of Obstructive Sleep Apnea The CASA Score Study
An observational study of Obstructive Sleep Apnea and Breathing, Sleep-Disordered, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Breathing, Sleep-Disordered, Muscle Weakness
- What is being tested?
- CASA score protocol to Non-obstructive sleep apnea Group, CASA score protocol to Mild obstructive sleep apnea Group and CASA score protocol to Moderate obstructive sleep apnea Group
- Type of treatment
- Pill or oral medicine
- How many people
- 319 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2019to 26 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults over 18 years old with sleep complaints undergoing he polysomnography in the private sleep clinic during the data collection period.
Who may be able to join
- Sleep complaints
- 18 years old or older
- Undergoing polysomnography in the private sleep clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035903
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Breathing, Sleep-Disordered, Muscle Weakness, Muscle Disorder, Face, Swallowing Disorder
- Being tested
- CASA score protocol to Non-obstructive sleep apnea Group, CASA score protocol to Mild obstructive sleep apnea Group, CASA score protocol to Moderate obstructive sleep apnea Group, CASA score protocol to Severe obstructive sleep apnea Group
- Keywords
- Obstructive sleep apnea, Polysomnography, Orofacial myofunctional disorders, Speech and Language and Hearing Science, Ultrasonography, Muscle Contraction, Muscle Strength, Sleep medicine
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Muscle Weakness, Muscular Diseases, Facies, Deglutition Disorders, Speech, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASA score protocol to Non-obstructive sleep apnea GroupDiagnostic test
Also called 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
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 GroupDiagnostic test
Also called 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
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 GroupDiagnostic test
Also called 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
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 GroupDiagnostic test
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-OSA Groups | Participants with apnea-hypopnea index < 5 events per hour of sleep. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: CASA score protocol to Severe obstructive sleep apnea Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the evaluation
Secondary outcomes (2)
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
Measured: 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.
Measured: Immediately after the evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start10 Jan 2019
- Primary completion26 Mar 2019
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Denis Martinez, Study chair, Hospital de Clinicas de Porto Alegre (HCPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980586
- Sponsor's protocol ID
- 2018-0314
- Acronym
- CASA
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28019049Harrington 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.
PubMed 16079039Guimaraes 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.
PubMed 19234106Lee 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.
PubMed 19189777Perri 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.
PubMed 23584845Lee 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.
PubMed 19189778Kim 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.
PubMed 25197815Yoshikawa 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.
PubMed 20623302Valbuza 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.
PubMed 21229321Prikladnicki 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.
PubMed 28933667Smith-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.
PubMed 24618841Prikladnicki 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.
PubMed 38217481
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cheeks Appearance as a Novel Predictor of Obstructive Sleep Apnea The CASA Score Study
- ClinicalTrials.gov ID
- NCT04980586
- Acronym / sponsor ID
- CASA / 2018-0314
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-OSA Groups | – | Diagnostic Test: CASA score protocol to Non-obstructive sleep apnea GroupParticipants with apnea-hypopnea index < 5 events per hour of sleep. |
| Mild OSA Group | – | Diagnostic Test: CASA score protocol to Mild obstructive sleep apnea GroupParticipants with apnea-hypopnea index > 5 < 15 events per hour of sleep. |
| Moderate OSA group | – | Diagnostic Test: CASA score protocol to Moderate obstructive sleep apnea GroupParticipants with apnea-hypopnea index > 15 < 30 events per hour of sleep. |
| Severe OSA Group | – | Diagnostic Test: CASA score protocol to Severe obstructive sleep apnea GroupParticipants with apnea-hypopnea index > 30 events per hour of sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 18 years old with sleep complaints undergoing he polysomnography in the private sleep clinic during the data collection period.
Key inclusion criteria (3 listed)
- Sleep complaints
- 18 years old or older
- Undergoing polysomnography in the private sleep clinic
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASA score protocol to Non-obstructive sleep apnea GroupAlso: 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 EndoscopyCASA 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. | Diagnostic test | Non-OSA Groups |
| CASA score protocol to Mild obstructive sleep apnea GroupAlso: 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 EndoscopyCASA 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. | Diagnostic test | Mild OSA Group |
| CASA score protocol to Moderate obstructive sleep apnea GroupAlso: 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 EndoscopyCASA 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. | Diagnostic test | Moderate OSA group |
| CASA score protocol to Severe obstructive sleep apnea GroupAlso: 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 EndoscopyCASA 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. | Diagnostic test | Severe OSA Group |
Primary outcome
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.
2 secondary outcomes
Thickness evaluation of specific orofacial muscles
Time frame: Immediately after the evaluation
Tongue and Cheeks pressure
Time frame: Immediately after the evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 28019049Agha 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.
- Background: PubMed 16079039Harrington 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.
- Background: PubMed 19234106Guimaraes 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.
- Background: PubMed 19189777Lee 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.
- Background: PubMed 23584845Perri 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.
- Background: PubMed 19189778Lee 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.
- Background: PubMed 25197815Kim 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.
- Background: PubMed 20623302Yoshikawa 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.
- Background: PubMed 21229321Valbuza 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.
- Background: PubMed 28933667Prikladnicki 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.
- Background: PubMed 24618841Smith-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.
- Derived from this study: PubMed 38217481Prikladnicki 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.
- Our first study in diagnostic accuracy in obstructive sleep apnea and the basis to this study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Denis Martinez study chair
Hospital de Clinicas de Porto Alegre (HCPA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Breathing, Sleep-Disordered, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cheeks appearance (time frame: Immediately after the evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980586, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.