Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576310
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Predictive Factors for Dental Occlusal Changes in the Treatment of Obstructive Sleep Apnea With Mandibular Advancement Appliance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APNEAMOUVE
Brief Summary:
This research addresses obstructive sleep apnea syndrome OSAS affecting 6-12 of French adults often treated with mandibular advancement devices MADs MADs may lead to occlusal modifications causing a 50 treatment abandonment rate The study employs surface electromyography to assess masticatory muscle activity before and during MAD use correlating it with occlusal changes after 6 months The primary goal is to determine dental displacement profiles post-6-month MAD treatment providing insights for personalized care and minimizing treatment failures
Detailed Description:
In this exploratory electro-pathophysiological study our objective is to provide a significant contribution to understanding the underlying mechanisms of occlusal modifications associated with mandibular advancement device MAD treatment in patients suffering from obstructive sleep apnea syndrome OSAS Drawing from observational data the researchers aim to identify specific electrophysiological profiles linked to masticatory muscle activity correlating with occlusal changes after MAD treatment This innovative approach involves detailed data collection on electrophysiological profiles initial clinical characteristics pre-treatment and post-treatment follow-up data Focusing on patients from the dentistry department at Toulouse University Hospital the study seeks to establish correlations between muscle activity recorded before and during MAD treatment and occlusal changes ultimately defining electrophysiological patient profiles These profiles could potentially guide personalized care anticipating risks of occlusal modifications and reducing treatment dropouts or failures
The study utilizes diverse exams-orthopantomogram optical impressions surface electromyography polysomnography and research questionnaires Data collected pre- and post-mandibular advancement device treatment for six months will innovatively analyze the links between masticatory muscle activity and occlusal changes aiming to define specific electrophysiological patient profiles
In this research participation in the protocol seamlessly integrates into routine care at the Odontology Department of the Toulouse University Hospital The visits include the provision of the orthosis at 3 weeks T1 with EMGs and digital occlusal analysis The 6-week follow-up visit T2 adjusts therapeutic propulsion subjectively resolving symptoms related to OSAS At the T0 visit the researchers collect the polysomnographic monitoring before fitting the orthosis carried out in the patients reference sleep laboratory to assess treatment efficiencyThe end-of-research visit 6 months after T0 comprehensively collects data including questionnaires on stress anxiety sleep quality and quantity oral habits temporo mandibular dysfunction pain and quality of life Moreover the researchers collect the polysomnographic monitoring after 3 months fitting the orthosis carried out in the same patients reference sleep laboratory than before fitting the orthosis
The study utilizes diverse exams-orthopantomogram optical impressions surface electromyography polysomnography and research questionnaires Data collected pre- and post-mandibular advancement device treatment for six months will innovatively analyze the links between masticatory muscle activity and occlusal changes aiming to define specific electrophysiological patient profiles
In this research participation in the protocol seamlessly integrates into routine care at the Odontology Department of the Toulouse University Hospital The visits include the provision of the orthosis at 3 weeks T1 with EMGs and digital occlusal analysis The 6-week follow-up visit T2 adjusts therapeutic propulsion subjectively resolving symptoms related to OSAS At the T0 visit the researchers collect the polysomnographic monitoring before fitting the orthosis carried out in the patients reference sleep laboratory to assess treatment efficiencyThe end-of-research visit 6 months after T0 comprehensively collects data including questionnaires on stress anxiety sleep quality and quantity oral habits temporo mandibular dysfunction pain and quality of life Moreover the researchers collect the polysomnographic monitoring after 3 months fitting the orthosis carried out in the same patients reference sleep laboratory than before fitting the orthosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None