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Completed

NCT Number: NCT03725189

Photophlethysmography Evaluation of Pulse Waveform

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Normal University

Taipei, 106, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria:
  • Ability to understand consent (no proxy consent) in English or Chinese.
  • Self-Reported ability to undertake a 20 minute cycling activity at 60-70% exercise intensity.
  • 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.
  • Exclusion criteria:
  • Inability to finish a 20 min cycling activity in 60-70% exercise intensity.
  • Adverse reaction to adhesive tape.
  • Raynaud's phenomenon
  • Angina or recent myocardial infarction (previous 6 months)

Treatment and study plan

PPG during exercise

Device

PPG use for pulse waveform evaluation of healthy exercise group

Primary outcomes

  1. Harmonic measures (C1-C10) by PPG device

    Time frame: 70 minutes on Day 1 for resting, exercise, and cool down measurements

    C1-C10 by PPG device

Secondary outcomes

  1. Demographic Information

    Time frame: Day 1

    Collected from patients by questionnaire

  2. General health

    Time frame: Day 1

    General health questionnaire

  3. Weight

    Time frame: Day 1

    Weight

  4. Height

    Time frame: Day 1

    Height

  5. Body mass index (BMI)

    Time frame: Day 1

    Body mass index (BMI)

  6. Diastolic blood pressure (DBP)

    Time frame: 70 minutes on Day 1 for resting, exercise, and cool down measurements

    iHealth Feel Wireless blood pressure monitor

  7. Systolic blood pressure (SBP)

    Time frame: 70 minutes on Day 1 for resting, exercise, and cool down measurements

    iHealth Feel Wireless blood pressure monitor

  8. HRV measures (SDNN, HF, LF and HF/LF parameters)

    Time frame: 70 minutes on Day 1 for resting, exercise, and cool down measurements

    emWave 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

  9. Heart rate and Heart Rate Variation

    Time frame: 70 minutes on Day 1 for resting, exercise, and cool down measurements

    emWave Pro Plus

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Taiwan Normal University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2018
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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