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临床试验/NCT02627937
NCT02627937Unknown不适用

Clinical Predictors of Pediatric Obstructive Sleep Apnea/Hypopnea Syndrome

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
88
试验地点
1
主要终点
Clinical predictors for apnea/hypopnea index (AHI)

研究概览

简要总结

The purpose of this study is to develop adequate and satisfactory tools using reliable clinical and physical factors in predicting pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) and allow greater access to appropriate therapy in children.

详细描述

The prevalence of OSAHS is estimated to be about 1% to 4% in children, however, it is frequently underdiagnosed because of the difficulties for evaluation.Current diagnostic approaches are based on the patient's history, clinical presentation and physical examination, endoscopy, and radiological imaging examinations, and confirmation is made by the current gold standard of full-night polysomnography (PSG). Previous studies have reported the use of a clinical history, physical examination and questionnaires for predicting pediatric OSAHS but there were lacking of adequate and satisfactory results. Despite the potential diagnostic benefits, PSG for pediatric patients are not routinely used in clinical practice. Therefore, to obtain a reliable, valid, and easily-performed diagnostic or screening tool for the clinical assessment of pediatric OSAHS is essential for the cost-effective care of these patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children (younger than 18 years old and older than 2 years old) with symptoms of snoring and then were confirmed to having obstructive sleep apnea/hypopnea syndrome by a comprehensive polysomnography

排除标准

  • patients with substance abuse problems or the long-term usage of medications known to affect sleep, craniofacial abnormalities or neuromuscular disorders, Down syndrome, cerebral palsy, mucopolysaccharidoses, Prader-Willi syndrome, history of psychosis, central sleep apnea syndrome, or previous airway surgery including tonsillectomy and/or adenoidectomy were excluded from the study.

结局指标

主要结局

Clinical predictors for apnea/hypopnea index (AHI)

时间窗: up to 4 months

When all variables were analyzed individually with the AHI, Spearman rank correlation analysis was used to explore the relationships between clinical predictor variables and AHI.Significant variables were entered into stepwise multiple linear regression analysis to identify independent predictors for pediatric OSAHS and to develop a predictive equation for AHI values.

次要结局

  • Anthropometric measurements: tonsil size grading(up to 4 months)
  • Anthropometric measurements: modified Mallampati grade (aka updated Friedman's tongue position(up to 4 months)
  • Apnea/hypopnea index (AHI)(up to 4 months)
  • Anthropometric measurements: body mass index z-score (BMI z-score)(up to 4 months)
  • Snoring visual analogue scale (Snoring VAS)(up to 4 months)
  • Anthropometric measurements: uvular length(up to 4 months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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