Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 6
- 主要终点
- Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).
详细描述
This is a multi- center, open label study to evaluate the accuracy of Somnarus device when compared with overnight polysomnographic measurements.
The study includes the following steps:
Screening the database or advertising among cardiologists, neurologists, pulmonologists and Ear Nose and Throat (ENT) specialists to identify potential subjects.
Initial visit, includes:
- Consent discussion and signature
- History, vital signs, and physical exam
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
The two sets of data (PSG and Somnapatch) were scored independently. Therefore it was masked what set of data belonged to what individual.
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign the informed consent
- •Able to comply with visits and follow ups included in this protocol
- •Ages 20-85 years
排除标准
- •An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
- •Skin rash on the nose or on the maxillary area.
- •A history of skin allergy to medical tape, and hypoallergenic tapes.
- •A history of skin cancer on the nose or on the maxillary area.
- •A history of the base of skull fractures, facial fractures
研究组 & 干预措施
SomnaPatch
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
干预措施: SomnaPatch (Device)
Polysomnography
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
干预措施: Polysomnography (Device)
结局指标
主要结局
Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)
时间窗: 1 night
AHI is the number of apneas and hypopneas that occur over an hour during the course of the night. The SomnaPatch and PSG were wore simultaneously over the night. The results from the SomnaPatch and PSG were compared per individual for agreement
次要结局
未报告次要终点