Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure

Background: Obstructive sleep apnea (OSA) is a common respiratory disorder associated with various complications, including cardiovascular, metabolic, and cognitive issues. Continuous positive airway pressure (CPAP) therapy can effectively reduce sleep apnea events and decrease the incidence of related complications. However, studies have shown that approximately half of OSA patients attempting CPAP therapy either cannot tolerate CPAP at all or only partially comply with it. Oropharyngeal rehabilitation (OPR), which involves isometric and isotonic exercises, can enhance the muscle tone of the tongue, pharynx, and soft palate. OPR may serve as one of the treatment options for OSA. Nevertheless, there is limited literature exploring the combined treatment approach of CPAP and OPR.

Methods：This study will recruit 30 200 adult OSA patients, who will be divided into two four groups: Control, OPR, CPAP alone and CPAP+OPR. The OPR training in OPR and CPAP+OPR groups will consist of home-based exercises performed for 30-45 minutes per session, once 1-2 session a day, five 3-5 days a week, over a period of three months. The training will be monitored using a strength sensor, and the intensity of the exercises will be adjusted every two weeks month during hospital visits. Both CPAP and CPAP+OPR groups will continue to wear CPAP every night, while the control group will receive monthly sleep hygiene education. The severity of OSA, upper airway space, tongue muscle length/thickness, tongue muscle strength/endurance, sleep quality, and CPAP usage report will be assessed using polysomnography, computed tomography scans, sonography, tongue muscle function tests, sleep quality questionnaires, and CPAP mask pressure at baseline and after three months of treatment.

Expected outcomes：

1. Compared to the group using only CPAP, the CPAP + OPR group will have an increased upper airway space volume after a 3-month follow-up. The upper airway space volume is negatively correlated with CPAP pressure and positively correlated with tongue muscle strength. 2. After 3 months of OPR treatment, the CPAP + OPR group will show an increase in tongue muscle strength, which is negatively correlated with CPAP pressure. 3. After 3 months of OPR treatment, both the OPR group and the CPAP+OPR group showed greater improvements in upper airway muscle function and greater reductions in obstructive sleep apnea severity and clinical symptoms compared to the control group and the CPAP group respectively.

• Tongue Muscle Strength [Time frame: Baseline and 12 weeks post intervention]
• Tongue Muscle Endurance [Time frame: Baseline and 12 weeks post intervention]
• Pharyngeal Airway Volume [Time frame: Baseline and 12 weeks post intervention]
• Cross Section Area on the Tip of Epiglottis [Time frame: Baseline and 12 weeks post intervention]
• Anterior to Posterior Distance on the Tip of the Epiglottis [Time frame: Baseline and 12 weeks post intervention]
• Lateral Distance on the Tip of Epiglottis [Time frame: Baseline and 12 weeks post intervention]
• Sleep Quality [Time frame: Baseline and 12 weeks post intervention]
• Daytime Sleepiness Level [Time frame: Baseline and 12 weeks post intervention]
• Tongue Muscle Thickness [Time frame: Baseline and 12 weeks post intervention]
• Median Pressure in Continuous Positive Airway Pressure [Time frame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months]
• Median Usage Hours of Continuous Positive Airway Pressure [Time frame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months]