跳至主要内容
临床试验/NCT06357039
NCT06357039已完成不适用

Validation Study of an Artificial Intelligence-based Sleep Stage Classification for a Home Sleep Tracking Device

PNAPS Health Informatics and Space Technologies Inc.1 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2023年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
305
试验地点
1
主要终点
Sleep Stages Classification Accuracy

研究概览

简要总结

In this study, a two-part recursive convolutional neural networks model was developed, extracting features for each epoch window independently from before and after sleep onset (epoch encoder), and then trained in the context of long-term relationships in the sleep process (sequence encoder), using an approach similar to human expert classification based on information from single-channel forehead EEG and PPG (IR, Green, Red). The classification is based on guidelines from the American Academy of Sleep Medicine and calculated six parameters: total sleep duration (TST), wake (W), N1, N2, N3, and REM.

The validation study of the developed model and the device was conducted at the Sleep Disorders Centre of the Istanbul Medical Faculty using concurrent polysomnographic data from 305 male and female patients aged 18 to 65 years.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants suffering from sleep disorders
  • •Participants sent to PSG test by neurologists, pulmonologists, psychiatrists, and otolaryngologists

排除标准

  • •Anyone who has been diagnosed as having a contagious skin disease
  • •Participants who do not have consent to have an additional device in their forehead area
  • •Incomplete of sleep measurement

结局指标

主要结局

Sleep Stages Classification Accuracy

时间窗: 4-5 months

The collected EEG data were classified according to Cohen's kappa (\>85), which is considered successful in the literature. Initially the open source codes YASA, tinysleepnet and attentionsleep have been implemented. These codes yielded kappa 0.64, accuracy 0.80, kappa 0.69, accuracy 0.79 and kappa 0.65, accuracy 0.78 respectively. The values obtained do not correspond to those reported in the classification articles. Subsequently, 29 participants from our own dataset were tested in these classifications as a preliminary test, with poor results. On an individual basis, the highest cappa score was 0.51. Development of our own classification system is in progress.

Interoception analysis from PPG data collected from facial skin

时间窗: 4-5 months

According to our preliminary analyses, we found that the intermediary rhythm (0.12-0.18 Hz) associated with interoception is also present in sleep patients. In one participant, for example, a value of 0.19 was obtained as a ratio of total sleep time. In addition, an intermediary rhythm is observed in all stages of sleep, including wakefulness, light sleep, deep sleep and REM.

次要结局

未报告次要终点

研究者

发起方
PNAPS Health Informatics and Space Technologies Inc.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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