Validation Study of Sleep Tracking Devices

PNAPS Health Informatics and Space Technologies Inc.305 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

305

Conditions

Sleep Sleep Disorder

Interventions

Sleep tracking deviceDEVICE

In addition to polysomnography, a device containing EEG+PPG sensors for sleep classification was placed on the forehead, and another device containing PPG and accelerometer sensors was placed on the wrist. The wrist to which the device is attached is randomly assigned.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participants suffering from sleep disorders * Participants sent to PSG test by neurologists, pulmonologists, psychiatrists, and otolaryngologists Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Sleep Stages Classification Accuracy

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.

Time frame: 4-5 months

Interoception analysis from PPG data collected from facial skin

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.