Identification of Patients With Clinically Relevant Sleep Apnea With a Contactless Device in Rehabilitation Clinic
试验速览
- 阶段
- 不适用
- 发起方
- Sleepiz AG
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Binary classification of the apnea severity
研究概览
简要总结
To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients.
The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic.
The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI >= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18years
- •Ability and consent to undergo electrophysiological routine assessment
- •Informed Consent as documented by signature
- •In-patients of RehaClinic Bad Zurzach
排除标准
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Cardiac pacemaker or another implanted electrical device
- •Women who are pregnant or breastfeeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
结局指标
主要结局
Binary classification of the apnea severity
时间窗: 1 night
Precision of binary classification of subjects based on their sleep apnea severity (apnea-hypopnea index (AHI) \>= 15) made by Sleepiz One, compared to PG data manually scored by expert sleep scorers
次要结局
未报告次要终点