Effects of Myofunctional Therapy With an M-health Application Airway Gym in Severe Apnea/Hypopnea Sleep Obstructive Syndrome: A Randomized Multicentre Control Trial

INTRODUCTION Obstructive sleep apnea/hypopnea syndrome (OSAHS) has become one of the more serious health problems worldwide (Mendes et al., 2014). Because of its relationship with obesity, its prevalence and incidence have increased. It is associated with morbidities such as cardiovascular and cerebrovascular diseases. The classic treatment of this disease is based on dietary measures, weight loss, and exercise, and the use of a continuous positive airway pressure (CPAP) machine.

Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered breathing (Camacho et al., 2015). MT is based on daily exercises using the oropharyngeal muscles in an attempt to strength them and facilitate opening of the airway. OSAHS originates from the suboptimal function of the dilator muscles of the airway. Therefore, MT is a therapy designed theoretically to deal with the underlying mechanism of this disease (Korhan et al., 2015). MT is based on oropharyngeal exercises described by diagrams, videos, and weekly instructions from a myofunctional therapist. The patient is instructed to perform the exercises regularly, for at least 3 months, and for 30 min daily. In some cases, patients perform exercises by themselves at home without substantial feedback and without giving precise information to the therapist about their performance of the exercises (O'Connor et al., 2019).

Most existing mobile health (mHealth) apps for OSAHS focus on diagnosis of snoring or OSAHS (Isetta et al., 2017), while a few are designed to promote adherence to treatment with CPAP (Camacho et al., 2015). To our knowledge, there are no apps that focus on the treatment of OSAHS. However, mobile technology could be especially valuable in treating OSAHS patients because of its potential to promote patient empowerment and self-management (Iftikhar et al., 2017).

One of the best treatments for OSAHS is exercise and weight loss (Iftikhar et al., 2018). Because patients' time is limited, the investigators consider that there will be a greater probability of their performing the exercises if they are able to do wherever and whatever. Therefore, the investigators designed and developed a novel mHealth app to promote oropharyngeal exercises while interacting with a smartphone. In this prospective randomized multicenter clinical trial, the investigators aim to evaluate adherence to the app and its effectiveness in a group of patients (AirwayGym group, AGG) with severe OSAHS compared with a control group (CG) of similar patients.

HYPOTHESIS The regular use of the AirwayGym app, which is designed to perform and increase adherence to MT, will improve OSAHS in patients with severe disease ,apnea hypopnea index (AHI)>30) by increasing the tone of their upper airway muscles.