Az obstruktív alvási apnoe kezelésében az okklúziós változások előrejelző tényezői mandibuláris fejlesztő készülékkel (APNEAMOUVE)

Patients with obstructive sleep apnea (OSA) treated with a mandibular advancement device (MAD), monitored for changes in masticatory muscle activity and occlusal modifications over a 6-month period. The study involves routine clinical visits and additional assessments including electromyography (EMG) with and without the appliance, optical impressions, digital occlusion recordings, patient diaries, and questionnaires on quality of life, temporo mandibular dysfunction pain, oral habits, stress and anxiety, and sleep evaluation.

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).

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®)

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.

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.

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.

As a percentage of voluntary mandibular protrusion and in mm of advancement

Conventional and with a medical titration aid device

Difference in :

- Body Mass Index (BMI),

- Duration of MAD wear,

- Frequency of MAD wear.

Measured by the Short Form Survey (SF-36)

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.