Validation of Sleep Monitoring Algorithm Based on Smart Watches

NCT ID: NCT06696196

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-14

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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smart watch

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.

Group Type EXPERIMENTAL

smart watches(wearable devices)

Intervention Type 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.

Interventions

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smart watches(wearable devices)

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pei-Lin Lee, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201503059RSA

Identifier Type: -

Identifier Source: org_study_id

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