Clinical trial NCT06576310: Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Official title: Evaluation of Predictive Factors for Dental Occlusal Changes in the Treatment of Obstructive Sleep Apnea With Mandibular Advancement Appliance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: MAD therapy
side effect
Dental occlusion
electromyography
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with sleep apnea treated with a mandibular advancement device

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 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).

Eligibility criteria: Inclusion Criteria:

* Patient with complete dentition (up to second molars)
* Polysomnography or polygraphy
* Diagnosis of OSA
* Patient receiving OAM treatment at the Odontology Department of Toulouse University Hospital
* Patient with contemporary panoramic and lateral cephalometric X-rays (common practice) taken at the time of orthotic treatment
* Individual affiliated with or covered by a social security scheme
* Voluntary, informed, written consent, signed by both participant and investigator (prior to inclusion and any necessary research-related examinations).

Exclusion Criteria:

* Inability to provide informed consent
* Pregnant or breastfeeding patient
* Patient with curators, guardians, or legal protection

Primary outcomes:
measure: OCCLUSAL MODIFICATIONS AFTER 6 MONTHS OF OAM TREATMENT
timeFrame: 6 month
measure: PRIMARY EXPOSURE VARIABLE: MASTICATORY MUSCLE ACTIVITY
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
measure: OSA phenotype at T0 visit
timeFrame: baseline
measure: initial sleep assesment
timeFrame: baseline
measure: Therapeutic mandibular advancement assessed at the T2 visit
timeFrame: 6 weeks
measure: Titration modality assessed at the T2 visit
timeFrame: 6 weeks
measure: difference in Patient's clinical characteristics at 6 months
timeFrame: 6 months
measure: Clinical characteristics
timeFrame: 6 months
measure: Clinical characteristics
timeFrame: 6 months
measure: Patient's quality of life
timeFrame: baseline
measure: Patient's quality of life
timeFrame: 6 months
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Constance CUNY, MD
role: PRINCIPAL_INVESTIGATOR
References: