Photophlethysmography Evaluation of Pulse Waveform

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: PPG during exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
4) 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. 5) 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPG Group<br>Testing of PPG device in healthy adult population doing cardiovascular exercise | Device: PPG during exercise<br>* PPG use for pulse waveform evaluation of healthy exercise group<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photophlethysmograph, device, pulse waveform