跳至主要内容
临床试验/NCT05830227
NCT05830227招募中不适用

Evaluation of Infrared Thermal Imaging in Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome in Children

State Key Laboratory of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity

研究概览

简要总结

OSAHS is a common sleep breathing disorder in children, with the same incidence as childhood asthma, and is mainly caused by upper airway stenosis caused by tonsil/adenoid hyperplasia. Clinical findings show that children with OSAHS often present rhinitis symptoms and like rubbing eyes, but there is no evidence to suggest a correlation. Children with OSAHS suffer from recurrent hypoxemia during sleep, and the existing detection methods such as lateral nasopharyngeal radiographs and electronic nasopharyngoscopy can only reflect the structural and morphological changes of the oral, nasal and pharyngeal tissues, but cannot prove their functional status. Previous studies have found that infrared thermal imaging can reflect the oral, nasal and pharyngeal inflammation of patients, and the infrared expression of patients' frontal region and eyes can also reflect the physiological changes caused by sleep deprivation.

详细描述

In this project, the children were divided into four groups: primary snoring, critical OSAHS, mild OSAHS and moderate to severe OSAHS, and the tests were completed, including lateral nasopharyngeal radiographs, infrared detection of oropharynx and pharynx, infrared detection of frontal area and eye area, intelligence and behavior scale assessment, etc. Furthermore, the correlation between infrared detection and obstructive sleep apnea hypopnea index, peripheral blood oxygen saturation, adenoid hyperplasia degree of nasopharyngeal lateral film as parameters were analyzed, and the sensitivity and specificity of infrared detection was determined to confirm the diagnostic value of OSAHS. It provides a theoretical basis for finding a convenient, non-damaging, non-radiation, visual and suitable for children functional image detection method.

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
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 2 to 14 with SDB related symptoms

排除标准

  • Congenital abnormalities of the nose and throat or airway;
  • craniofacial deformity
  • Neuromuscular dysregulation
  • History of adenoids and/or tonsillectomy.

结局指标

主要结局

Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity

时间窗: 2025

Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity (sleep breathing parameters OAHI and LSpO2)

次要结局

未报告次要终点

研究者

发起方
State Key Laboratory of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lijun Zeng

Guangzhou Institute of Respiratory Disease

Guangzhou Institute of Respiratory Disease

研究点 (1)

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