Photophlethysmography Evaluation of Pulse Waveform

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: PPG during exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 106
    • National Taiwan Normal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPG Group; Testing of PPG device in healthy adult population doing cardiovascular exercise	Device: PPG during exercise; PPG use for pulse waveform evaluation of healthy exercise group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harmonic measures (C1-C10) by PPG device	C1-C10 by PPG device	70 minutes on Day 1 for resting, exercise, and cool down measurements

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Information	Collected from patients by questionnaire	Day 1
General health	General health questionnaire	Day 1
Weight	Weight	Day 1
Height	Height	Day 1
Body mass index (BMI)	Body mass index (BMI)	Day 1
Diastolic blood pressure (DBP)	iHealth Feel Wireless blood pressure monitor	70 minutes on Day 1 for resting, exercise, and cool down measurements
Systolic blood pressure (SBP)	iHealth Feel Wireless blood pressure monitor	70 minutes on Day 1 for resting, exercise, and cool down measurements
HRV measures (SDNN, HF, LF and HF/LF parameters)	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	70 minutes on Day 1 for resting, exercise, and cool down measurements
Heart rate and Heart Rate Variation	emWave Pro Plus	70 minutes on Day 1 for resting, exercise, and cool down measurements

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Taiwan Normal University
• Investigators: Principal Investigator: Ka-Kit Hui, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: device; Photophlethysmograph; pulse waveform
• Other Study ID Numbers: 00000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No