Validation of Sleep Monitoring Algorithm Based on Smart Watches

NCT06696196 | Completed

• 1 other identifier: 201503059RSA
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Polysomnography; sleep staging; sleep efficiency; wearable devices; smart watches

Outcome Measures

Primary Outcomes (1)

• sleep stages derived from smartwatch

  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.

  12 months

Secondary Outcomes (1)

• sleep efficiency derived from smartwatch

  12 months

Study Arms (1)

smart watch

EXPERIMENTAL

This study will use a prototype (MediaTek Sleep Watch) to acquire PPG, body movements, skin temperature, and skin conductance to validate the algorithm of sleep staging and sleep efficiency assessment. PSG will be used as gold standard for statistical analysis.

Device: smart watches(wearable devices)

Interventions

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.

smart watch

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Pei-Lin Lee, M.D., PhD

  Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: November 20, 2024
• Study Start: December 14, 2015
• Primary Completion: January 24, 2017
• Study Completion: April 30, 2017
• Last Updated: November 20, 2024

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)