The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular rethognathia: a study protocol for a multicenter randomized controlled trial

Abstract Background: Pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) is a multifactorial syndrome caused by many risk factors, such as craniofacial anomalies, adenotonsillar hypertrophy, obesity and airway inflammation. Although new treatment patterns have recently been proposed, treatment methods for children remain particularly challenging and controversial. This randomized controlled trial was designed to investigate the efficacy of adenotonsillectomy and/or orthodontic treatment for mild OSAHS children with mandibular rethognathia.Methods: A sample of 352 children with mild OSAHS and mandibular rethognathia, aged between 7 and 10 years, will be enrolled in the study. They will be randomized into four groups – the drug treatment group, the surgical treatment group,the orthodontic treatment group, or the surgery and postoperative orthodontic group. After randomization they will receive treatments within 4 weeks. Outcome assessment will take place at the following points: (1)baseline, (2) 7 months after the treatment starting point, (3) 12 months after the treatment starting point, and (3) 24 months after the treatment starting point. The primary endpoint of the trial is the mean change of obstructive apnea/hypopnea index. Other endpoints will consist of the lowest oxygen saturation, apnea index, and hypopnea index assessed by polysomnogram, subjective symptoms (assessed by the OSA-20 questionnaire), cephalometric measurements and morphologic analysis of the upper airway.Discussion: The results of this study will provide valuable evidence for the merits and long-term efficacy of different treatment approaches and contribute to facilitating the multidisciplinary treatment of pediatric OSAHS.Trial registration: Clinicaltrials.gov, ID: NCT03451318. Registered on 2 March 2018 (last update posted 19 April 2018).