Clinical Study of Customized Adjustable Oral in Treatment of Patients With Obstructive Sleep Apnea Syndrome
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|ClinicalTrials.gov Identifier: NCT03729895|
Recruitment Status : Unknown
Verified September 2018 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Syndrome||Device: Adjustable Oral Appliance||Not Applicable|
Obstructive sleep apnea syndrome (OSAS) represents the most common nocturnal respiratory disease characterized by repetitive episodes of partial or complete upper airway collapse or narrowing during sleep,associated with phasic oxygen desaturation.Failure to recognize this condition could lead to an increased risk of cardiovascular diseases, daytime sleepiness, road accidents, a reduced cognitive capacity, with a decline of the quality of life.According to the American Association of Sleep Medicine,the diagnostic standard of the OSAS is the polysomnographic exam, which allows to assess the gravity of OSAS in relation to the Apnea Hypopnea Index (AHI) within an hour:slight (AHI<5), moderate (5<AHI<30) and severe (AHI>30). Epidemiological investigations has shown that the prevalence rate of OSAS is 2-4% of the total population,whereas the percentage of undiagnosed OSAS remains very high with progression to dangerous complications.
OSAS treatment modalities include proper body position, slimming,continuous positive air pressure(CPAP),surgical procedures and oral appliances use. OA are dental devices that improve OSAS by producing a structural change of the upper airways, in order to mechanically increase the pharyngeal diameters, keep the tongue from falling backwards and to stiffen the pharyngeal muscles longitudinally.Recently, OAs is growing more popular due to its superiority in the treatment of the OSAS.It offers a non-invasive form of treatment but also achieve a good therapeutic effect. Traditionally, the effects of functional appliances are evaluated using two-dimensional (2D) radiographs, but the reproducibility of 2D is complex, and overlapping images are difficult to assess. Cone-beam computed tomography (CBCT) provides more accurate and reproducible imaging for assessing all craniofacial skeletal structures.
The objective of this study was to evaluate, in a 6-months follow-up study, the effect of costumed adjustable oral appliance in OSAS patients both through the comparison of the polysomnographic analysis, and also through the volumetric measurements of the pharyngeal airway by using the cone beam computed tomography.
Twenty-four patients,aged 18 to 50 years,in whom the diagnosis of OSAS was made following polysomnography in a sleep laboratory will be enrolled between September 2018 and November 2018.All patients will also undergo a systematic dental examination by a dentist, which put an indication to the use of OA, based also on the craniofacial features assessment. The Epworth Sleepiness Scale (ESS) will be used to evaluate daytime sleepiness.
They then will be fitted with a costumed adjustable oral appliance. The appliances are taken with a mandibular advancement of 2-3 mm and vertical rise of 4-5 mm, that is, the vertical position set at the minimum occlusal elevation to allow mandibular advancement and to avoid backward rotation. The participants were asked to wear the test appliance for 7 nights, and in case of compliance,application it every night at least for 6 months. The selected patients will be record their usage of the appliance and any adverse effects in a treatment journal.
The research focus on the following outcomes: sleep apnea and the the volumetric changes of the upper airway. All patients were radiographically evaluated with a specific diagnostic examination: the cone beam computed tomography scan. For each patient, 3 CBCT scans were performed positioning his head in a neutral way and were performed without swallowing or respiratory movements during inspiration at rest: the first one before the therapy, the second after 3 months and the second after 6 months. Data obtained through CBCT scans have been exported in DICOM format and analyzed with a specific software (MIMICS-Materialise Interactive Medical Image Control System, Leuven, Belgium).The pharyngeal area around the velopharynx and oropharynx has been considered in which the origin of apneas is mainly found.Three planes have been built, an upper, a middle, and lower one, all perpendicular to the median sagittal plane of symmetry to obtain 2 areas, a superior and an inferior one.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Twenty-four patients diagnosed with OSAS in different degrees,who cannot tolerate continuous positive air pressure use and reject a surgical approach, were treated with adjustable customized oral appliances and evaluated with cone-beam computed tomography and polysomnography.|
|Masking:||None (Open Label)|
|Official Title:||Clinical Effect and Upper Airway Changes of Customized Adjustable Oral Appliance in the Treatment of Patients With Obstructive Sleep Apnea Syndrome|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: patients with OSAS in different degrees
OSAS patients will be treated with an adjustable oral appliance and evaluated with cone-beam computed tomography and polysomnography.
Device: Adjustable Oral Appliance
Adjustable Oral Appliance consist of plastic maxillary occlusal splint，mandible occlusal splint and adjustable connecting rod.It could offer a non-invasive form of treatment but also achieve a good therapeutic effect
- change in apnea hypopnea index(AHI) [ Time Frame: 3,6 and 10 months ]the change from apneas hypopneas per hour of sleep registration of the subjects fitted with oral appliance at 3,6 and 10 months
- change in apnea index(AI) [ Time Frame: 3,6 and 10 months ]the change from apneas per hour of sleep registration of the subjects fitted with oral appliance at 3,6 and 10 months
- change in lowest blood oxygen saturation [ Time Frame: 3,6 and 10 months ]the change from the ratio of the content of oxyhaemoglobin to the content of oxygenic hemoglobin in the blood of the subjects at 3,6 and 10 months
- change in minimal volume/transverse diameter/sagittal diameter/cross-sectional area of the velopharyngeal segment of the subjects [ Time Frame: 3,6 and 10 months ]the change from velopharyngeal segment of upper airway is the region between two planes pass separately through the posterior nasal spine point (PNS) and the tip of soft palate point(U),which are parallel to frankfort horizontal plane(FH) after 3,6 and 10 months
- change in minimal volume/transverse diameter/sagittal diameter/cross-sectional area of the oropharyngeal segment of upper airway [ Time Frame: 3,6 and 10 months ]the change from oropharyngeal segment of upper airway is the region between two planes pass separately through the highest point of epiglottis(EP) and the tip of soft palate point(U),which are parallel to frankfort horizontal plane(FH) at 3,6 and 10 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729895
|Contact: biao Guo, firstname.lastname@example.org|
|Chiese PLA 307 hospital|
|Beijing, Beijing, China, 100071|
|Contact: rongjian Lu, doctor 0086-010-66947334 email@example.com|
|Study Director:||rongjian Lu, doctor||Chinese PLA 307 Hospital|