Skip to main content
OpenTrials
Completed

NCT Number: NCT06696196

Validation of Sleep Monitoring Algorithm Based on Smart Watches

In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

Sleep efficiency has a great impact on the performance of work and learning during the day. If persons lack of sleep for a long time, they might be prone to memory loss and emotional instability. Traditionally, polysomnography (PSG) has been proved as golden results to assess the sleep efficiency. However, to accomplish the assessment, subjects are asked to sleep in a certified sleep laboratory or a sleep centers for nights. Under the supervision of nurses, subjects are put many adhesive electrodes on the body and connect wires to PSG, which causes discomfort. In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Forty male or female subjects are recruited from those visiting Department of Medicine for health check up
  • Subjects aged 20 to 65

Exclusion criteria

  • Refuse to participate
  • Arrhythmia
  • Active infection
  • Active neurologic event
  • Shift worker
  • Substance abuse
  • Fitted with implantable medical electronics, such as cardiac pacemakers and defibrillators

Treatment and study plan

smart watches(wearable devices)

Device

Participants will be asked to wear two smart watches simultaneously. The first smart watch is a dedicated prototype for validating algorithm developed by MediaTek. The second smart watch is Basis Peak. These watches are going to acquire PPG, body movements, skin temperature, and skin conductance.

Primary outcomes

  1. sleep stages derived from smartwatch

    Time frame: 12 months

    Comparing sleep stages detected by a smartwatch(hh:mm) with the sleep stages of an overnight PSG(N1 (%), N2 (%), N3 (%), REM(%), Arousal index (/h) to validate the effectiveness of the smartwatch.

Secondary outcomes

  1. sleep efficiency derived from smartwatch

    Time frame: 12 months

    Comparing sleep efficiency(%) detected by a smartwatch with the sleep efficiency(%) from an overnight PSG to validate the effectiveness of the smartwatch.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.