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Photophlethysmography Evaluation of Pulse Waveform

Pilot Study of the Effect of Physical Activity on Pulse Waveform Monitored by a Novel Photophlethysmographic Device

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03725189
Enrollment
42
Registered
2018-10-30
Start date
2019-05-01
Completion date
2020-12-01
Last updated
2020-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Photophlethysmograph, device, pulse waveform

Brief summary

Aim 1. To explore a novel, non-invasive PPG technology for purposes of monitoring heart rate variability and pulse waveform by harmonic resonance analysis. Aim 2. To analyze collected data to determine whether it provides useful information about other measures of underlying health.

Detailed description

The proposed study will first investigate whether a novel PPG device will be able to measure the harmonic-analysis indexes of the blood pressure waveform (BPWs) to provide information about arterial pulse transmission (by monitoring arterial pulse waveform, Cn) and cardiovascular regulatory activities (by monitoring coefficients of variation, CVn). Secondarily, data on Cn and CVn could be useful for detecting the arterial elastic properties induced by external stimulation such as exercise, cold stimulation, mental stress, acupuncture, medications such as antihypertensive drugs, or pathological factors such as metabolic syndrome, and breast cancer. The collected data may thus provide information about underlying health. Photoplethysmography (PPG) is a non-invasive optical technique for evaluating the pulse and hemodynamic changes in frequency. The device obtains a volumetric measurement of an organ via optical illumination (e.g LED). PPG has been used to determine the PaO2, heart rate, and blood pressure (systolic blood pressure, SBP and diastolic blood pressure, DBP) at fingertip and harmonic proportion at fingertip or from the radial artery waveform at the wrist. However, to the investigator's knowledge, this is the first preliminary study to determine the effects of physical activity on harmonic proportion evaluating by PPG at fingertip. Ultimately, this data may help to develop a non-invasive, external device that could rapidly detect information about cardiovascular and underlying health.

Interventions

DEVICEPPG during exercise

PPG use for pulse waveform evaluation of healthy exercise group

Sponsors

National Taiwan Normal University
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

4\) Inclusion criteria: 1. Ability to understand consent (no proxy consent) in English or Chinese. 2. Self-Reported ability to undertake a 20 minute cycling activity at 60-70% exercise intensity. 3. Ability and willingness to abstain from use of medications for three days preceding cycling activity, smoking/intense exercise/alcohol for 12 hours preceding cycling activity, and caffeine intake for 4 hours preceding cycling. 5\)

Exclusion criteria

1. Inability to finish a 20 min cycling activity in 60-70% exercise intensity. 2. Adverse reaction to adhesive tape. 3. Raynaud's phenomenon 4. Angina or recent myocardial infarction (previous 6 months)

Design outcomes

Primary

MeasureTime frameDescription
Harmonic measures (C1-C10) by PPG device70 minutes on Day 1 for resting, exercise, and cool down measurementsC1-C10 by PPG device

Secondary

MeasureTime frameDescription
General healthDay 1General health questionnaire
WeightDay 1Weight
HeightDay 1Height
Body mass index (BMI)Day 1Body mass index (BMI)
Demographic InformationDay 1Collected from patients by questionnaire
Systolic blood pressure (SBP)70 minutes on Day 1 for resting, exercise, and cool down measurementsiHealth Feel Wireless blood pressure monitor
HRV measures (SDNN, HF, LF and HF/LF parameters)70 minutes on Day 1 for resting, exercise, and cool down measurementsemWave Pro plus, SDNN indicates standard deviation of normal to normal R-R intervals, where R is the peak of a QRS complex (heartbeat). LF and HF represent power in low- and high-frequency ranges
Heart rate and Heart Rate Variation70 minutes on Day 1 for resting, exercise, and cool down measurementsemWave Pro Plus
Diastolic blood pressure (DBP)70 minutes on Day 1 for resting, exercise, and cool down measurementsiHealth Feel Wireless blood pressure monitor

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026