Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
NCT Number: NCT06576310
Acronym: APNEAMOUVE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea Syndrome
Interventions: DEVICE: Mandibular Advancement Device
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 118
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2026-12-01

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.

Primary Outcome Measures: OCCLUSAL MODIFICATIONS AFTER 6 MONTHS OF OAM TREATMENT, 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®), 6 month|PRIMARY EXPOSURE VARIABLE: MASTICATORY MUSCLE ACTIVITY, 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., 6 month
Other Outcome Measures: OSA phenotype at T0 visit, The phenotype is classified as:

* Typical OSA with somnolence,
* Female OSA with insomnia, depression, and a relatively strong association with arterial hypertension and metabolic comorbidities,
* OSA in elderly subjects with comorbidities,
* OSA in young subjects with predominantly nocturnal respiratory symptoms and minimal daytime disturbance., baseline|initial sleep assesment, 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., baseline|Therapeutic mandibular advancement assessed at the T2 visit, As a percentage of voluntary mandibular protrusion and in mm of advancement, 6 weeks|Titration modality assessed at the T2 visit, Conventional and with a medical titration aid device, 6 weeks|difference in Patient's clinical characteristics at 6 months, Difference in :

- Body Mass Index (BMI),, 6 months|Clinical characteristics, - Duration of MAD wear,, 6 months|Clinical characteristics, - Frequency of MAD wear., 6 months|Patient's quality of life, Measured by the Short Form Survey (SF-36), baseline|Patient's quality of life, 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., 6 months