Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Video analysis score
研究概览
简要总结
The aim of the study is to evaluate the value of a video recording of the child sleep on smartphone made by the parents and comparing it to ventilatory polygraphy (PV) on the one hand and to the clinical evaluation method (clinical examination + Spruyt and Gozal score) on the other hand.
详细描述
Obstructive sleep apnoea syndrome (OSAS) is a common disorder in school-aged children with an estimated prevalence of 1-4%. The main etiology is adeno-amygdala hypertrophy. Adenoamygdalectomy, which involves the removal of tonsils and adenoids, is a common procedure. In the majority of cases, it allows the healing of OSAS. The surgical indication is currently based on clinical arguments sensitized by the calculation of a severity score (Spruyt and Gozal score). However, this procedure is not without complications: pneumopathy (for 1.5% of procedures), blood transfusion for haemorrhage (1/400 to 1/2 500), death due to haemorrhage (1/35 000 to 1/50 000).
Currently there is no indication to perform a preoperative sleep recording for this surgery. This recording will only be made in case of associated comorbidities (obesity, craniofacial malformations, neurological disorders...).
The current growth and diffusion of smartphones in the population provides a simple technical means of video recording the child's sleep. More and more parents come to an ENT consultation with a video recording of their child's sleep on a smartphone. The current recommendations say to take these data into account without any study having evaluated the value of such records. The video recording of a snoring child's sleep has already been evaluated by Sivan et al in 1996. This study finds a good correlation between polysomnographic recording and a method of rating video recordings of sleep in children with adeno-amygdala hypertrophy without associated comorbidities.
The aim of this study is therefore to evaluate the value of this video recording on smartphone made by the parents by comparing it to ventilatory polygraphy (PV) on the one hand and to the clinical evaluation method (clinical examination + SHS score) on the other hand. If our hypothesis is correct, smartphone video recording could be an additional tool to the clinical diagnosis of OSA in children with adeno-amygdala hypertrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 3 and 10 years old consulting an ENT for snoring noted by the entourage (parents).
- •Tonsil hypertrophy ≥ 2 (Brodsky classification).
- •Entourage in possession of a smartphone allowing a video recording (under Android format).
排除标准
- •Chronic cardiovascular, neurological, metabolic (overweight, obesity) or associated pulmonary pathology.
- •Syndromic craniofacial malformations.
研究组 & 干预措施
children with adenoamygdala hypertrophy
干预措施: smartphone homemade video (Behavioral)
结局指标
主要结局
Video analysis score
时间窗: at day 1
The primary judging criterion will be the 10-minute video analysis score (independent variable). The dependent variable will be the status obtained with PV (pathological or normal), defined according to the standard criteria of the American Academy of Sleep Medicine 2012
status obtained with PV
时间窗: at day 1
The primary judging criterion will be the 10-minute video analysis score (independent variable). The dependent variable will be the status obtained with PV (pathological or normal), defined according to the standard criteria of the American Academy of Sleep Medicine 2012
次要结局
- Video analysis score(at day 1)
- score from the Spruyt and Gozal questionnaire(at day 1)