Photophlethysmography Evaluation of Pulse Waveform

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725189
• Other study ID #: 00000
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• PPG during exercise
PPG use for pulse waveform evaluation of healthy exercise group

Locations

Country	Name	City	State
Taiwan	National Taiwan Normal University	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic Information	Collected from patients by questionnaire	Day 1
Secondary	General health	General health questionnaire	Day 1
Secondary	Weight	Weight	Day 1
Secondary	Height	Height	Day 1
Secondary	Body mass index (BMI)	Body mass index (BMI)	Day 1
Secondary	Diastolic blood pressure (DBP)	iHealth Feel Wireless blood pressure monitor	70 minutes on Day 1 for resting, exercise, and cool down measurements
Secondary	Systolic blood pressure (SBP)	iHealth Feel Wireless blood pressure monitor	70 minutes on Day 1 for resting, exercise, and cool down measurements
Secondary	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
Secondary	Heart rate and Heart Rate Variation	emWave Pro Plus	70 minutes on Day 1 for resting, exercise, and cool down measurements