Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Measure of change in OSA severity
研究概览
简要总结
The aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (CPAP), versus no treatment.
详细描述
Consenting patients and their parents will choose one of three options (within the context of medical/craniofacial appropriateness): CPAP, orthodontic intervention, or to remain untreated (control). It would be ideal if each patient was randomly assigned to one of three groups. However, in our study, random allocation is not an option as the established clinical pathways for treatment, financial resources, and physiological presentation of the patient determines the appropriate intervention. In each group, the effectiveness of the intervention will be analyzed through the evaluation of sleep parameters, medical history, questionnaire responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and at 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with obstructive sleep apnea by polysomnography who presented with a failure in treatment with surgical removal of the tonsils and adenoid tissue --adenotonsillectomy (T&A).
- •Patients diagnosed with obstructive sleep apnea but for whom T&A was not an option following assessment by Otolaryngology.
排除标准
- •Autism spectrum
- •Down syndrome
- •Pulmonary hypertension
- •Cystic fibrosis
结局指标
主要结局
Measure of change in OSA severity
时间窗: baseline and 12 months
Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months
Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 12 months
时间窗: baseline and 12 months
PSQ consists of total 22 questions with choices of answer; Yes or No. Yes answer will be coded as 1 and No answer coded as 0. Sum of 22 questions will be compared.
次要结局
- Change from baseline body mass index (BMI) at 12 months(baseline and 12 months)