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Clinical Trials/NCT06696196
NCT06696196
Completed
Not Applicable

Validation of Sleep Monitoring Algorithm Based on Smart Watches

National Taiwan University Hospital1 site in 1 country35 target enrollmentDecember 14, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea Syndrome
Sponsor
National Taiwan University Hospital
Enrollment
35
Locations
1
Primary Endpoint
sleep stages derived from smartwatch
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2015
End Date
April 30, 2017
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • sleep efficiency derived from smartwatch(12 months)

Study Sites (1)

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