Comparative evaluation of the efficacy of customized maxillary oral appliance with mandibular advancement appliance as a treatment modality for moderate obstructive sleep apnea patients-protocol for a randomized controlled trial.

backgroundObstructive sleep apnea (OSA) is due to the obstruction of the upper airway during sleep. This condition is often associated with multiple symptoms and co-morbidities. There are many treatment options mentioned in the literature to manage OSA, among which interventional option of continuous positive airflow (CPAP) and non-interventional option, i.e., mandibular advancement device (MAD), which is an oral appliance (OA), are the most preferred ones. This study aims to evaluate the efficacy of customized maxillary oral appliances with mandibular advancement devices in moderate OSA patients.

methodsA prospective interventional study with a randomized controlled trial will be carried out involving 40 participants (sample size), with an apnea-hypopnea index (AHI) > 15-30, recorded on polysomnography (PSG). Study participants will be randomly divided into the following treatment groups: control group or group subjected to mandibular advancement device (MAD, n=20) and second group subjected to customized maxillary oral appliance (CMOA, n=20). Baseline assessment of apnea/hypopnea index (AHI), oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth Sleepiness Scale will be done. Then both study group participants will receive their respective appliances. And after one month and three months of delivery of the appliance, all the parameters, i.e., AHI, oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth Sleepiness Scale will be re-evaluated and compared with the baseline measurements. Descriptive and analytical statistics will be done. SPSS (Statistical Package for Social Sciences) Version 20.1 will be used as statistical software. The statistical significance between the two groups after one month and three months will be evaluated at p< 0.05. DISCUSSION: We expect, customized maxillary oral appliance to be more efficient in managing moderate OSA, in comparison with MAD. If the hypothesis of the present study is confirmed, then this customized maxillary appliance will be quoted as a "gold standard" for managing moderate OSA.

trial registrationCTRI/2020/07/026936 Registered 31 July 2020.