University Hospital of Toulouse
Toulouse, France
Location status: Recruiting
NCT Number: NCT06576310
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Toulouse, France
Location status: Recruiting
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 patient's reference sleep laboratory) to assess treatment efficiency.(The 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 patient's reference sleep laboratory than before fitting the orthosis).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In this research, participation in the protocol seamlessly integrates into routine care at the Odontology Department of the University Hospital of Toulouse. 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 patient's reference sleep laboratory) to assess treatment efficiency. The end-of-research visit (6 months after T1) 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 patient's reference sleep laboratory than before fitting the orthosis).
Time frame: 6 month
assessment of occlusal modifications after 6 months of mandibular advancement device (OAM) treatment. Dental occlusion will be measured using digital occlusal analysis with OCCLUSENS® (Bausch; Köln, Germany), considering the extent of contacts (centroid) and their intensity (%), and through morphometric analysis based on optical impressions obtained pre and post-treatment using the TRIOS optical camera (3Shape, Dentsply®)
Time frame: 6 month
The primary exposure of interest is the activity of masticatory muscles measured by EMG, in the form of motor-evoked potentials (MEPs in µV/s). This measurement will be conducted at the T1 visit when the orthosis is provided to the patient (3 weeks after inclusion) and 6 months after the inclusion visit. At each measurement time, surface EMG will be conducted bilaterally (4 locations in total), both with and without OAM. The association between muscle activity at inclusion and occlusal modifications will be studied for the primary objective, while the association between muscle activity after 6 months of treatment and occlusal modifications will be explored as a secondary objective.
Time frame: baseline
The phenotype is classified as:
Time frame: baseline
Sleep will be assessed with polysomnography Oxygen desaturation index A normal oxygen saturation level should be about 96 to 97%. When blood oxygen levels drop below 90% Oxygen Desaturation Index is considered slightly abnormal. When blood oxygen levels dip even lower to 80 or 89%, they are considered moderately abnormal. Any blood oxygen levels below 80% are considered severe.
Time frame: 6 weeks
As a percentage of voluntary mandibular protrusion and in mm of advancement
Time frame: 6 weeks
Conventional and with a medical titration aid device
Time frame: 6 months
Difference in :
Time frame: 6 months
Time frame: 6 months
Time frame: baseline
Measured by the Short Form Survey (SF-36)
Time frame: 6 months
Measured by the SF-36 questionnaire. Scoring the 36-Item Health Survey is a two-step process. First, all items are scored so that a high score defines a more favorable health state.
In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
In step 2, items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores.
Hence, scale scores represent the average for all items in the scale that the respondent answered.
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Evaluation of Predictive Factors for Dental Occlusal Changes in the Treatment of Obstructive Sleep Apnea With Mandibular Advancement Appliance
Acronym: APNEAMOUVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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