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Validation Study of Sleep Tracking Devices

NCT06357039 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 305

Last updated 2024-04-25

No results posted yet for this study

Summary

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.

Conditions

  • Sleep
  • Sleep Disorder

Interventions

DEVICE

Sleep tracking device

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.

Sponsors & Collaborators

  • Analog Devices

    collaborator UNKNOWN

  • PNAPS Health Informatics and Space Technologies Inc.

    lead OTHER

Principal Investigators

  • Asuman Çevik, Master's · PNAPS Health Informatics & Space Technologies Inc.

  • Hasan Birol Çotuk, PhD · Marmara University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2023-05-31
Completion
2023-07-17

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357039 on ClinicalTrials.gov