Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Dentistry, University of Alberta, Edmonton, Alberta, Canada
BMJ Open. 2022 Jun 15;12(6):e061651. doi: 10.1136/bmjopen-2022-061651.
Obstructive sleep apnoea (OSA) is a sleep-breathing disorder that seems likely to have long-term negative social and health consequences in children and adolescents. There are no established standard management approaches when the first line of therapy, the tonsillectomy and adenoidectomy (T&A), is not indicated or fails to address paediatric OSA (residual paediatric OSA). This protocol describes a prospective cohort study that aims to assess the effectiveness of orthodontic interventions for managing residual paediatric OSA in patients with concomitant craniofacial issues.
Children aged 6-16 years who with an OSA diagnosis and did not benefit from previous T&A or qualified for T&A will be recruited. Orthodontic intervention(s), when adequately indicated (maxillary expansion, mandibular advancement or maxillary complex advancement with skeletal anchored headgear), and a control (orthodontic intervention declined) cohorts will be involved. A sample size of 70 participants (n=35 per cohort) is planned. Effectiveness data will be assessed through nocturnal polysomnography, a craniofacial index, sleep questionnaires and medical records. Additionally, the association of residual OSA and two comorbidities, obesity and asthma, will be investigated through assessing blood, urine and saliva metabolites. The changes on body mass index will also be investigated as a secondary outcome. Other additional outcomes, including association between residual paediatric OSA and periodic limbs movement, restless leg syndrome, insomnia, and the use of abiometric shirt to sleep monitoring purposes will also be considered. All participants will be followed up for 12 months after treatment allocation. The effectiveness of the intervention will be analysed by the assessment of sleep parameters, medical history (from medical chart reviews), questionnaire responses, craniofacial characteristics and metabolomic markers using an algorithm to be developed.
This study was approved by the Health Research Ethics Board-Health Panel, University of Alberta, Edmonton, Canada (Pro00084763). The findings will be shared with scientific and patient content-specific social network communities to maximise their impact on clinical practice and future research in the study topic.
NCT03821831; Pre-results.
阻塞性睡眠呼吸暂停（OSA）是一种睡眠呼吸障碍，如果儿童和青少年的一线治疗（扁桃体切除术和腺样体切除术（T&A））不适用或不能解决小儿 OSA（残余小儿 OSA），则可能会产生长期的负面社会和健康后果。目前尚无既定的标准管理方法。本方案描述了一项前瞻性队列研究，旨在评估正畸干预治疗合并颅面问题的残余小儿 OSA 的有效性。
将招募年龄在 6-16 岁之间、诊断为 OSA 且未从先前的 T&A 中获益或符合 T&A 适应证的患者。将涉及正畸干预（上颌扩张、下颌前伸或上颌复合体前伸与骨骼锚定头帽）和对照（正畸干预拒绝）两组。计划纳入 70 名参与者（每组 35 名）。有效性数据将通过夜间多导睡眠图、颅面指数、睡眠问卷和病历进行评估。此外，还将通过评估血液、尿液和唾液代谢物来研究残余 OSA 与两种合并症（肥胖和哮喘）之间的关联。体重指数的变化也将作为次要结果进行研究。其他额外的结果，包括残余小儿 OSA 与周期性肢体运动、不宁腿综合征、失眠以及使用生物测定衬衫进行睡眠监测目的之间的关系也将被考虑。所有参与者将在治疗分配后随访 12 个月。干预的有效性将通过评估睡眠参数、病史（从病历回顾中）、问卷回答、颅面特征和代谢组学标记物来分析，使用将要开发的算法。
本研究得到加拿大埃德蒙顿阿尔伯塔大学健康研究伦理委员会-健康小组的批准（Pro00084763）。研究结果将与科学和患者特定的内容网络社区共享，以最大限度地提高它们对临床实践和该研究主题未来研究的影响。
NCT03821831；预结果。
