Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to provide informed consent

Pregnant or breastfeeding patient

Patient with curators, guardians, or legal protection

Trial population

patients with sleep apnea treated with a mandibular advancement device

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mandibular Advancement Device

    Device

    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).

Treatment groups

118 Participants
are divided into 1 treatment group
Group A: OSA patients with mandibular advancement appliance1 intervention

Trial outcomes

Primary outcomes

1

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®)

Time frame
6 month
2

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.

Time frame
6 month

Secondary outcomes

Other outcomes

1

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.

Time frame
baseline
2

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.

Time frame
baseline
3

Therapeutic mandibular advancement assessed at the T2 visit

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

Time frame
6 weeks
4

Titration modality assessed at the T2 visit

Conventional and with a medical titration aid device

Time frame
6 weeks

Sponsors and contacts

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