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The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular retrognathia: study
Yuanyuan Li1,2, Jiali Wu3, Jinghan Guo2,4
1Department of Pediatric Dentistry, Shanghai Stomatological Hospital, Fudan University, Shanghai, China.
Insights
This study compares drug, surgical, and orthodontic treatments for mild pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) in children with mandibular retrognathia. Findings will guide effective multidisciplinary care for this challenging condition.
Area of Science:
- Pediatric Sleep Medicine
- Otolaryngology
- Orthodontics
Background:
- Pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) is complex, with risk factors including craniofacial anomalies and obesity.
- Current treatment for pediatric OSAHS is challenging and debated.
- This study focuses on mild OSAHS in children with mandibular retrognathia.
Purpose of the Study:
- To investigate the efficacy of adenotonsillectomy and/or orthodontic treatment in children with mild OSAHS and mandibular retrognathia.
- To compare different treatment modalities for pediatric OSAHS.
- To provide evidence for optimizing multidisciplinary treatment strategies.
Main Methods:
- A randomized controlled trial involving 352 children (aged 7-10 years) with mild OSAHS and mandibular retrognathia.
- Participants were randomized into four groups: drug treatment, surgical treatment, orthodontic treatment, or surgery with postoperative orthodontics.
- Outcomes were assessed at baseline, 7, 12, and 24 months, focusing on the apnea/hypopnea index, oxygen saturation, and subjective symptoms.
Main Results:
- The primary endpoint is the mean change in the obstructive apnea/hypopnea index.
- Secondary endpoints include lowest oxygen saturation, apnea index, hypopnea index, subjective symptoms (OSA-20 questionnaire), cephalometric measurements, and upper airway morphology.
- Data collection spans 24 months post-treatment initiation.
Conclusions:
- The study aims to provide valuable evidence on the merits and long-term efficacy of various treatment approaches for pediatric OSAHS.
- Results will aid in facilitating multidisciplinary treatment decisions.
- This research addresses a critical need for evidence-based interventions in pediatric sleep-disordered breathing.
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).
