Predictive Morphological Factors for Prescribing a Mandibular Advancement Device in the Therapeutic Approach of Obstructive Sleep Apnea

This study will present 66 adult patients diagnosed with mild or moderate OSA (5 <AHI ≤ 30/h) through polysomnography (PSG) level III, referred from pulmonology, otorhinolaryngology and/or neurology for treatment with MAD, who refuse or do not tolerate the therapeutic approach of CPAP, in the sleep unit of Hospital CUF Tejo. The randomization sequence will be generated by computer and kept confidential, in a sealed and opaque envelope, until the moment of recruitment. There will be 3 study groups:

Group A - Will perform pharyngeal CT with cephalometry and registration in maximum comfortable protrusion (MCP).

Group B - Will perform the DISE with registration in MCP. Group C - Will perform pharyngeal CT with cephalometry and recording in MCP + DISE with recording in MCP

In the first appointment, a complete anamnesis and a clinical examination will be carried out, where several items will be documented: Age, gender, BMI, mallampati index, neck, and waist circumference. The clinical interview will assess daytime sleepiness, nighttime snoring, and the patient's 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). Using a Likert scale, the ESS is a quantitative assessment tool for drowsiness or the propensity to fall asleep in eight everyday situations. This instrument has been used in various contexts, populations, and clinical conditions, emphasizing sleep-disordered breathing, namely OSA. The SSS is a three-question questionnaire that assesses the intensity, frequency, and duration of snoring, completed by patients and their bed partners. The SSS is internally consistent across patients, regardless of age and sex, and externally valid, as it has a high correlation with the respiratory disturbance index (RDI), AHI, and ESS. The SAQLI was created as a specific quality-of-life instrument for patients with OSAS. This is a 35-item questionnaire that assesses the adverse impact of OSA in four domains: daily animosity, social interactions, emotional state, and symptoms. Items are scored on a 7-point scale. Still, in the 1st consultation, a PSG level III will be prescribed to assess the possibility of OSA and a CT of the pharynx with cephalometric analysis and recording in MCP to assess the UA and the prognosis of advancement of the mandible in the UA collapse/s.

After confirmation of mild to moderate OSA and application of the inclusion and exclusion criteria, patients will be randomly allocated into 3 study groups, with the randomization sequence generated by computer and kept secret in a sealed and opaque envelope until the time of recruitment: