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Not Yet Recruiting NCT05677620

Predictive Factors for Prescribing a Mandibular Advancement Device for the Treatment of Obstructive Sleep Apnea

Conditions: Sleep Apnea, Obstructive

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: 1
Enrollment: 66
Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL

Location: Portugal

Summary

This project evaluates the morphological predictive factors for prescribing a mandibular advancement device in the therapeutic approach of Obstructive sleep apnea (OSA). The investigators will carry out the project with patients who travel to CUF Tejo Hospital to solve their sleep disturbance, namely cases of obstructive sleep apnea. The investigators designed three groups of 22 individuals each. The investigators will only include individuals after signing the informed consent. In the 1st appointment, the principal investigator will conduct a complete anamnesis and a clinical examination, where several items will be documented: Age, gender, body mass index, mallampati index, neck, and waist circumference. The clinical interview will assess the patient's daytime sleepiness, nighttime snoring, and quality of life through the respective questionnaires: the Epworth Sleepiness Scale (ESS), the snoring severity scale (SSS), and the Sleep Apnea Quality of Life Index (SAQLI). Still, in the 1st consultation, a level III Polysomnography (PSG) will be prescribed to assess the possibility of OSA, and a pharyngeal computed tomography (CT) with cephalometric analysis and recording in maximum comfortable protrusion to evaluate the Upper Airway (UA) and the prognosis of mandibular advancement in case of UA collapse. The other group will perform Drug-Induced Sleep Endoscopy (DISE) and CT with registration in maximum comfortable protrusion. Then, the investigators will make personalized and titled mandibular advancement devices (MAD). The measurements and PSG III questionnaires will be carried out after 1 and 6 months to evaluate the results.

Eligibility Criteria

Inclusion Criteria:Patients between 18 and 70 years of age with the indication for treatment with mandibular advancement device, who refused or cannot tolerate CPAP;Body Mass Index (BMI) between 19 and 34.9 Kg/m2;The presence of 8 healthy teeth or more per jaw (upper and lower );Maximum mandibular protrusion capacity of at least 6 mm.Exclusion Criteria:Significant nasal obstruction; chronic lung disease;Class III or IV congestive heart failure according to the New York Heart Association classification;Neuromuscular diseases or previous upper airway surgery unrelated to obstructive sleep apnea;Uncontrolled periodontitis;Tooth mobility;Orthodontic treatment;Dental prosthesis wholly or partially removable.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05677620). StuddyBuddy aggregates publicly available trial information.