Photophlethysmography Evaluation of Pulse Waveform

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: PPG during exercise

• Registration Number: NCT03725189
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Study Start: 2019-05-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-08
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPG Group	PPG during exercise	Testing of PPG device in healthy adult population doing cardiovascular exercise

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan Normal University; 🇨🇳 Taipei City, Taiwan