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Validation of Sleep Monitoring Algorithm Based on Smart Watches

National Taiwan University logo

National Taiwan University

Status

Completed

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Device: smart watches(wearable devices)

Study type

Interventional

Funder types

Other

Identifiers

NCT06696196
201503059RSA

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

smart watch
Experimental group
Description:
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.
Treatment:
Device: smart watches(wearable devices)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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