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

Yuanyuan Li, Jiali Wu, Jinghan Guo, Liming Yu, Jing Wang, Xiaoyan Li, Shuhua Xu, Min Zhu, Jinqiu Feng, Yuehua Liu, Yuanyuan Li, Jiali Wu, Jinghan Guo, Liming Yu, Jing Wang, Xiaoyan Li, Shuhua Xu, Min Zhu, Jinqiu Feng, Yuehua Liu

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 children who have mild OSAHS with mandibular retrognathia.

Methods: A sample of 352 children with mild OSAHS and mandibular retrognathia, who are 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 the children 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 (4) 24 months after the treatment starting point. The primary endpoint of the trial is the mean change in obstructive apnea/hypopnea index. Other endpoints will consist of the lowest oxygen saturation, apnea index, and hypopnea index assessed by polysomnography, 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 : NCT03451318. Registered on 2 March 2018 (last update posted 19 April 2018).

Keywords: Adenotonsillectomy; Mandibular retrognathia; Multicenter randomized controlled trial; Orthodontic treatment; Pediatric obstructive sleep apnea/hypopnea syndrome.

Figures

Fig. 1
Fig. 1
Flow chart of study design
Fig. 2
Fig. 2
The removable twin-block appliance combined with RME used in the orthodontic treatment
Fig. 3
Fig. 3
Cephalometric landmarks and indicators. S sella, N nasion, Po porion, Or orbitale, A subspinale, B supramental, Ui upper incisor, Uir upper incisor root, Li lower incisor, Lir lower incisor root, Me menton, Go gonion, UL upper lip anterior, LL lower lip anterior, FH the Frankfort plane, MnP the mandibular plane, Ep the aesthetic plane, UL-Ep distance between UL and the aesthetic plane, LL-Ep distance between LL and the aesthetic plane
Fig. 4
Fig. 4
Morphologic analysis of upper airway. a Localization planes of CBCT images. b Segmented upper airway. c Minimum cross-sectional area (CSAm) on the axial slice of the CBCT image. PNS posterior nasal spine, TUV tip of the uvula, TEP tip of the epiglottis, ATCV anteroinferior aspect of the vertebral body of the third cervical vertebra, AP anteroposterior

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