Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- We aim to compare the novel diagnosis method with nocturnal polysomnography which is the reference method to diagnose sleep disordered breathing.
研究概览
简要总结
Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly regarding protective dilator reflexes of upper airway. Preliminary results have suggested that the use of this parameter in diagnosis algorithm such as linear discriminant analysis and random forest could predict the presence of sleep apnea syndrome in almost 98% of patients. Our study aims at validating a new diagnosis method of sleep disordered breathing which will be compared with nocturnal polysomnography, the reference method to diagnose sleep disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device which allows an automatic measurement of the pharyngeal sensation. The use of this parameter in diagnosis algorithm will be compared with polysomnographic results.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •consecutively included patients with suspicion of sleep apnea syndrome
- •patients who have signed the informed consent form
- •patients with body mass index less than or equal 30 kg/m2
排除标准
- •body mass index more than 30 kg/m2
- •pharyngeal infection or allergic rhinitis less than 2 weeks before recordings
- •craniofacial anomalies and/or limited mouth opening and/or teeth position compromising mouthpiece installation and stability during measurement
- •instable dentures
- •exaggerated gag reflex preventing pharynx examination
- •no visibility of the soft palate
- •systemic or topical anti-inflammatory treatments
- •treatments that may increase the occurence of nocturnal respiratory events and/or leading to daytime sleepiness and cognitive impairment
- •cardiac failure, or symptoms suggesting cardiac failure
- •history of stroke
- •contraindication for using xylocaine spray
- •no affiliation to national insurance
- •patient participating in another research study involving drugs that may interfere with sleep recordings and/or measurement of pharyngeal sensation
- •patient subjected to exclusion period following participation in another research study
结局指标
主要结局
We aim to compare the novel diagnosis method with nocturnal polysomnography which is the reference method to diagnose sleep disordered breathing.
时间窗: Measurement performed the morning following the nocturnal polysomnography
次要结局
- We will determine the severity of sleep apnea for which pharyngeal sensitivity is predictive of sleep apnea syndrome. To simplify the procedure, we will precise the role of pharyngeal anesthesia in the diagnostic predictive value of the algorithm.(similar to primary outcome measure)