Validation of Sleep Monitoring Algorithm Based on Smart Watches

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome

• Registration Number: NCT06696196
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2015-12-14
• Primary Completion: 2017-01-24
• Study Completion: 2017-04-30
• Status Verified: 2017-06
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2024-11-17
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

1. Refuse to participate
2. Arrhythmia
3. Active infection
4. Active neurologic event
5. Shift worker
6. Substance abuse
7. Fitted with implantable medical electronics, such as cardiac pacemakers and defibrillators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
sleep stages derived from smartwatch	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 Outcome Measures

Name	Time	Method
sleep efficiency derived from smartwatch	12 months	Comparing sleep efficiency(%) detected by a smartwatch with the sleep efficiency(%) from an overnight PSG to validate the effectiveness of the smartwatch.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan