Influence of oropharyngeal exercises in the adherence and efficacy of mandibular advancement device therapy in patients with moderate obstructive sleep apnea: a multicentre randomized clinical trial pilot study
Sleep apnea
A myofunctional and anatomical evaluation of the patient diagnosed with obstructive sleep apnea/hypopnea syndrome (OSAHS) will be conducted in the same week as the polysomnography is performed. During this evaluation, patients are blindly examined by an otorhinolaryngologist and blindly allocated to each group. Randomization will be simple randomization depending on the order the patient attends the Ear, Nose and Throat (ENT) consultation. The total duration of therapy will be 3 months. There will be four arms: 1. Sham therapy: expiratory exercises daily performed and written in a diary. 2. Myofunctional therapy: oropharyngeal exercises performed by an APP Airway Gym followed by telemedicine 3. Mandibular advancement device therapy: use of a titratable mandibular advancement device (NOA device) 4. Mandibular advancement device and oropharyngeal exercises: a combination of both Subsequently, the muscle tone of the genioglossus muscle and the buccinator muscle are evaluated with IOPI, taking three measurements of each one and using the highest value. The tone of the tongue muscles is measured with the digital spoon, taking three measurements and using the highest one. Then is referred to the dentist to adapt MAD at the maximum distance allowed. DISTRIBUTION OF HOSPITAL VISITS: Visits during the study are distributed as follows: SELECTION VISIT: The patient diagnosed with OSAHS at a pulmonology laboratory by means of an initial sleep study (with measurement of baseline AHI, night-time oxygen desaturation index and the lowest night-time oxygen saturation figures) is evaluated vis-à-vis the inclusion and exclusion criteria and then informed about the study. After reading the information and having any doubts solved, the patient accepts and signs the informed consent form in duplicate, taking one copy home. ONE-OFF VISIT: The patient is evaluated by the otolaryngologist and fills in the sleepiness questionnaires, the TDS and IOPI. Exercises are explained and the gr
1. Aged between 18 and 75 years 2. Diagnosis of moderate OSAHS (AHI between 15-30) without having had previous experience of said condition and not undergoing treatment due to different circumstances 3. Not having undergone any previous treatment for OSAHS 4. Signed informed consent (IC) form
1. Cognitive or neurological deficit 2. Inability to answer questionnaires 3. Severe alcoholism 4. Presence of craniofacial malformations 5. Active neoplastic disease 6. History of prior orofacial muscle rehabilitation therapy and any prior apnoea treatment which may modify the study results (surgery, MAD, continuous positive airway pressure [CPAP]) 7. Not having a smartphone 8. Temporomandibular joint dysfunction 9. Absence of dentition to wear a MAD