Photophlethysmography Evaluation of Pulse Waveform

• ClinicalTrials.gov Identifier: NCT03725189
• Recruitment Status: Completed
• First Posted: October 30, 2018
• Last Update Posted: December 10, 2020
• Sponsor: University of California, Los Angeles
• Collaborator: National Taiwan Normal University
• Information provided by (Responsible Party): Kakit P. Hui, MD, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Device: PPG during exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Study of the Effect of Physical Activity on Pulse Waveform Monitored by a Novel Photophlethysmographic Device
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: December 1, 2020
• Actual Study Completion Date: December 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Taiwan

National Taiwan Normal University

Taipei City, Taiwan, 106

Sponsors and Collaborators

University of California, Los Angeles

National Taiwan Normal University

Investigators

• Principal Investigator: Ka-Kit Hui, MD; University of California, Los Angeles

More Information

• Responsible Party: Kakit P. Hui, MD, Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03725189
• Other Study ID Numbers: 00000
• First Posted: October 30, 2018
• Last Update Posted: December 10, 2020
• Last Verified: December 2020

• 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

Keywords provided by Kakit P. Hui, MD, University of California, Los Angeles:

Photophlethysmograph; device; pulse waveform