Validation Study of Sleep Tracking Devices

PNAPS Health Informatics and Space Technologies Inc.

Status: Completed

Conditions: Sleep Disorder; Sleep

Treatments: Device: Sleep tracking device

Study type: Observational

Funder types: Other

Identifiers

NCT06357039

1065371 (Other Grant/Funding Number)

09.2023.422

2220124 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 305 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

305 participants in 2 patient groups

Female

Description:

Participants aged 18-65 who identify as female for biological

Treatment:

Device: Sleep tracking device

Male

Description:

Participants aged 18-65 who identify as male for biological

Treatment:

Device: Sleep tracking device