Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04980586
Study type Observational
Source Hospital de Clinicas de Porto Alegre
Contact
Status Completed
Phase
Start date January 10, 2019
Completion date April 26, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A