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

NCT06576310 | Not Yet Recruiting

• 1 other identifier: RC31/24/0024
• Study Type: observational
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

MAD therapy; side effect; Dental occlusion; electromyography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• OSA phenotype at T0 visit

  baseline

• initial sleep assesment

  baseline

• Therapeutic mandibular advancement assessed at the T2 visit

  6 weeks

Study Arms (1)

OSA patients with mandibular advancement appliance

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.

Device: Mandibular Advancement Device

Interventions

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).

OSA patients with mandibular advancement appliance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with sleep apnea treated with a mandibular advancement device

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Bites and Stings

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Constance CUNY, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constance CUNY, MD

CONTACT

+33615282467; cuny.c@chut-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 28, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08